Wounds and Injuries

All Conditions

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Musculoskeletal Diseases

Behaviors and Mental Disorders

Rare Diseases

Fractures, Bone

Multiple Myeloma

Neoplasms, Plasma Cell

Spinal Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

Myeloma patients with documented x-ray evidence of spinal fractures.

Myeloma patients with bony disease in the spine without existing fractures.

kyphoplasty

Jeffrey Wolf, MD

Sigurd Berven, MD

Thomas Martin, MD

The purpose of this study is to create a prospective database of patients with myeloma affecting the spine. This database will define changes in health-related quality of life over time, and the effect of incident fractures and their treatment on specific measures of pain, physical function, pulmonary function, and future fractures. In 2008, the UCSF Myeloma Service was actively caring for 347 patients with myeloma, of which 150 patients had lytic lesions on radiographs, and 100 had a known vertebral fracture. This population, as well as any new myeloma patients, will serve as the source of the study population.

The UCSF Adult Hematology Program maintains a data base of all patients with a diagnosis of multiple myeloma seen in the Clinic. As patients are treated, relapse, receive new treatment, are transplanted, or pass away, these data are entered into this Multiple Myeloma Data Base (MMDB).

The MMDB will be expanded to include parameters to identify those patients with myeloma affecting the spine. A recruitment letter will be sent to all patients in the MMDB identified as having myeloma affecting the spine asking if they would be interested in participating in this study.

Patients who agree to participate in the study will be given an appointment to meet with Dr. Wolf or Dr. Martin to discuss the study and if willing, to sign the informed consent document. They will have an exam and history taken that includes fracture history.

Patients who have signed consent will be sent for thoracic-lumbar spine films (unless they had prior spine films taken within the last 3 months). Those with normal films will not be eligible to be enrolled to the study. Those with abnormal spinal films will then be sent for MRI of the spine, pulmonary function testing, and meeting with Dr. R. Yonge who will administer the various QOL tests described below.

All eligible established and new patients will be invited to participate in the prospective study. Patients who sign the informed consent will be included in the prospective study. A minimum of 25 patients with vertebral fractures and 25 patients without fractures, will be observed to measure the impact of fractures on health-related quality of life. Study enrollment will be complete when 25 patients without a new fracture and 25 patients with a new fracture treated by balloon kyphoplasty have been enrolled.

Health-Related Quality of Life (QOL), Physical and Respiratory Function in Patients With Myeloma Affecting the Spine

Prospective Observation Study of Health-related QOL, Physical Function & Respiratory Function in Patients w/ Myeloma Affecting Spine: The Impact of Disease,Fractures & Effect of Vertebral Augmentation w/ Kyphoplasty

Medtronics, Inc.

University of California, San Francisco

Symptoms and General Pathology

Nervous System Diseases

Pain

Spinal Cord Neoplasms

Spinal Neoplasms

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

STAR™ Tumor Ablation System

Radiofrequency-targeted vertebral augmentation (RF-TVA)

StabiliT® Vertebral Augmentation System

Jack Jennings, MD

The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.

Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"

Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)

Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]

The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.

Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.

The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.

DFINE Inc.

Merit Medical Systems, Inc.

All cause mortality was collected. Of 35 enrolled subjects, 9 died due to disease progression and 2 died due to other reasons (one was listed as hospice and the other as "unknown"). There were 0 participants considered to have experienced Serious Adverse Events (SAEs) and the participants who died due to disease progression and other reasons are not considered SAEs.

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)

StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)

No Previous Radiation Therapy

Failed/Refuse Further Radiation Therapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Breast Cancer

Prostate Cancer

Prostate Cancer and Other

Small Cell Lung Cancer

Non-Small Cell Lung Cancer

Thyroid Cancer

Other

Primary Cancer

The BPI asks subjects to rate pain by circling the one number that best describes pain at its worst in the last 24hrs. 0=no pain and 10=pain as bad as (you) can imagine. Results are presented in response to Q3 of the BPI only (i.e. pain at its worst in the last 24hrs). This was accomplished using the BPI short form.

Brief Pain Inventory (BPI -Short Form) - 24 hour worst pain

Study was terminated due to difficulty with enrollment. Analysis of data is limited due to early termination of study and incomplete enrollment and completion of study subjects.

Casey Holland

Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks

Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks

Week 1

Week 2

Week 6

Brief Pain Inventory Q3 Worst Pain Score by Visit

Overall Study

Neoplasm Metastasis

Neoplastic Processes

Intra-operative radiation therapy followed by standard kyphoplasty

The radiation source is inserted into the lesion and switched on for a few minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and clinical applications of this device have been well studied.

Kypho-IORT

Maged Ghaly, MD

Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or potentially unstable spinal cord metastases. The primary objective is to evaluate the response rate of pain control when combining kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord metastases. Secondary objectives are (i.) to determine feasibility for unstable or potential unstable spine metastases; (ii.) to determine tolerability/side effects of the IORT within 90 days post-procedure; (iii.) to determine which clinical factors are prognostic of vertebral compression fracture

Approximately 20% of patients with spine metastasis present with unstable lesions, which represent a common therapeutic dilemma in patients with advanced stage cancer and limited survival time. Management necessitates spinal stabilization surgery such as laminectomy, vertebroplasty, or kyphoplasty for mechanical back pain control and irradiation for the underlying malignant process. Because of the limited survival time of patients with metastatic cancer, novel, more convenient treatment concepts to shorten the overall treatment time or hospitalization are desirable. We developed a novel approach to combine kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord metastases.

Patients treated with Kypho-IORT will receive a prescribed dose of 8 Gy in 1 fraction from The Intrabeam® Photon Radiosurgery System source. The target volume includes only the tumor. The technique of the operation and the delivery of radiotherapy has been described and published previously. TARGiT Academy training and requisite test cases have been completed prior to enrolling subjects on this study. The balloon kyphoplasty, which is an advancement of the vertebroplasty, is a treatment option for fractured vertebral bodies which utilizes bone cement to provide needed support.

Outcome measures will include complete or partial pain relief or a stable response at the index site requiring no increase in narcotic pain medication. Therefore, patients with complete or partial pain relief will be considered responders. Patients with complete or partial pain relief at the index site but a progressive response at the secondary site(s) will be considered non-responders.

Quality of Life Measurements. It is hypothesized that quality of life (QOL) will improve after Kypho-IORT due to rapid and durable pain control after spine treatment. In the current study, we will measure the QOL \[EORTC QLQ-C30 (version 3)\], the Brief Pain Inventory (BPI), ambulation , and steroid and narcotic use pre- and post-procedure at 1-week, 3-month, 6-month, 9-month, 1-year, and 2-year intervals. The involved spine will be imaged at 3-month intervals up to one year, and at 2 years post-procedure.

All the evidence to date supports the description of the Intrabeam as delivering an accurate and reliable dose. Physicists on site will be responsible for verifying the miniature x-ray source is operational prior to use and setting up the parameters within the control console software for treatment delivery. During the procedure, the control console monitors the system for safe and accurate dose delivery.

Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study

To evaluate the response rate of pain control when combining kyphoplasty, a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord metastases.

To determine the feasibility of delivered Kypho-IORT for unstable or potential unstable spine metastases.

To determine tolerability/side effects of the IORT based on defined MTD criteria (wound healing problems, infection, osteoradionecrosis, nerve and spinal cord damage, pathological fracture, secondary fractures/sintering progression and symptomatic or asymptomatic cement leakage within 90 days.

Local tumor control is defined as no recurrent tumor in the treated lesion. Patients will be regularly monitored as per the site's policy provided this meets the minimum trial criteria for follow-up with physical examination 1 week post treatment, and at 3 months, 6 months, 1 year, and 2 years post-treatment.

Overall survival will be the time interval between enrollment and death.

Evaluate the potential benefit of Kypho-IORT on change in and overall quality of life, in pain as measured by the Brief Pain Inventory (BPI); Ambulation, and EORTC QLQ-C30 (version 3).

The average daily morphine equivalent (mgs) used.

Northwell Health

Asst. Professor of Radiation Medicine

Neoplasms, Second Primary

The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon.

Samarium (153SM)

Hani Ashamalla, MD, FCCP

Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance.

The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.

Protocol:

1. Patients with bone metastases will be identified and discussed in the weekly joint Neuroscience meeting held in Radiation Oncology Department.
2. If the patient is eligible to this study, the protocol will be offered to him/her. If the patient accepts; informed consent will be obtained.
3. The case will be scheduled jointly by Neurosurgeon and Radiation Oncologist.
4. Radiation physicist orders the radioactive samarium.

During the procedure:

1. Neurosurgical procedure ( kyphoplasty/vertebroplasty) is performed as standard using . mild general sedation and local anesthesia.
2. Once a cavity is identified in fluoroscopy, the trocar is secured. The volume and pressure of the kyphoplasty balloon are recorded.
3. According to standard practice; only the radiation team (Radiation oncologist, Physicist) is handling the radioactive material. All work is done under sterile conditions.
4. Two mCi. of Samarium is prepared after serial dilution steps under radiation precautions in the department of radiation oncology and material is transferred to OR.
5. 0.5ml of "Head Cement" is administered first to act as a seal.
6. The Samarium is then introduced into the vertebral cavity using a 2-way valve by the Radiation Oncologist. Total of 0.5ml (Samarium+0.2ml radio opaque material)
7. The "Foot cement" (0.5 ml) is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon to flush any remains of radioactivity in the system.
8. The two way valve is then removed and the rest of kyphoplasty/vertebroplasty is ensued as per their ordinary protocol.
9. Final volume of cement injected is recorded.
10. After securing the wound, all devices, syringes, gloves and basins used for handling the radioactive substance are collected in a "red bag" and stored by radiation safety officer in the hot lab. till full radioactive decay.
11. The room is scanned after patient's discharge, any spillage should be reported to radiation safety officer and normal procedures for environmental protection are ensued.

Post Procedure:

1. Normal neurosurgical recovery room protocol is employed. No radiation precautions needed.
2. Patient can be discharged home. No delays because of radiation precautions
3. Once patient is cleared, a nuclear imaging scan is obtained with Gamma camera. The ratio of uptake in the vertebra to background is calculated. Moreover, Full body scan is obtained to identify other areas of uptake if any.
4. A second nuclear imaging scan is done on the 4th day of the procedure (Two half Lives) to document significant decay and calculate dose.
5. MRI/CT scan of the area treated should be done in 4 weeks to assess outcome.
6. Clinical follow up is obtained at 2, 4 weeks and in 3 months. Careful pain score assessment is included in each time (Use Study Flow Sheet)

Effect of Samarium on the Relief of Pain Due to Vertebral Metastases

Phase I/II Study of the Use of Vertebral Intracavitary Cement and Samarium (VICS) for Painful Vertebral Metastases

Measuring the pain by the Visual Analogue Scale

New York Presbyterian Brooklyn Methodist Hospital

Chairman of Radiation Oncology

IORT with Kyphoplasty IORT Device: Intrabeam®

IORT with kyphoplasty is give concurrently for the treatment of spinal metastases

IORT with Kyphoplasty

Intrabeam®

Beth Chiappetta, BSN

William Small, MD

The primary objective is to evaluate the tolerability (side effects) of the intraoperative radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord damage, and pathological fracture), and the secondary objective is to evaluate the effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor response).

Disease Background:

Bone metastases are the third most common site of metastatic spread, affecting 10% - 30% of all cancer patients. The spine remains the most common site of bone metastases, with incidence ranging from 30-70% depending on the primary tumour.

Spinal metastases can be a significant cause of morbidity for cancer patients: severe pain, bone fracture, nerve root or spinal cord compression, hypercalcemia, and limited mobility. Symptomatic spinal metastases are most frequently located in the thoracic spine (70%), followed by lumbar spine (20%) and cervical spine (10%). Up to 15% of all cancer patients with bone metastasis will suffer compression fracture leading to loss of function and the impairment of mobility, while more than 70% of the patients will experience severe cancer-related pain affecting quality of life. Newer systemic agents targeting specific pathway or molecule within the tumor milieu has led to a dramatic improvement in life expectancy for metastatic patients. Hence, effective palliative treatment options for spinal metastases is an important clinical issue in today's oncologic practice.

Current Practice:

The majority of patients with spinal metastases are initially managed medically with combination of analgesic medication, bisphosphonates, or biologic/chemotherapy agents.

When these patients develop severe pain refractory to medical options or there is a concern for neurologic dysfunction (i.e. vertebrate fracture, nerve root compression), they will be referred for palliative radiotherapy or surgical treatment options.

In the past decade, minimally invasive interventional therapies have become more popular to treat severe pain from spinal metastases, especially in patients with evidence of compression fracture. Vertebroplasty involves the percutaneous injection of cement into the vertebral body with the goals of pain alleviation and preventing further loss of vertebral body height. Similarly, in kyphoplasty (KYPHO), an inflatable balloon is used to create a cavity for the cement deposition, which restores height as well as provides pain relief. However, the immediate goal for both procedures is to achieve stabilization of the vertebral body and prevent further compression.

Investigators assessed the safety and efficacy of vertebroplasty and kyphoplasty for pain palliation in cancer patients. They performed ninety-seven procedures in fifty-six patients. The median age was 62 years. The procedure was well-tolerated and no post-operative complications or death were noted. There was a significant reduction in visual analog pain score (VAS): median pre-and postoperative VAS score was 7 and 2, respectively (P=0.001, student paired t-test). However, there concern for use of kyphoplasty alone in treatment of spinal metastases: the rate of re-treatment and variable duration of pain palliation. The rate of new compression fracture after balloon kyphoplasty in patients with malignant spinal fracture can be as high as 10%.

Non-surgical option to treat spinal metastases usually involves the use of external beam radiotherapy. The goals of radiation therapy are to alleviate pain, stabilize affected bone, and decrease tumor cells within the treated site. Radiotherapy is very effective in pain reduction, as 50-80% of all patients receiving palliative radiation will experience pain reduction. Pain reduction from ionizing radiation, in theory, is due to the direct analgesic effect on the nociceptors in the periosteum and electrolyte shift, which can convert pain-inducing tissue acidosis to tissue alkalosis. Furthermore, stabilization of the vertebral bodies can be achieved by decreasing number of tumor cells and hence, thereby changing the imbalance of osteoclast and osteoblast activity. The latter effect can increase re-mineralization. These effects will occur in 40-50% of patients after radiation therapy, but can take 4-6 weeks after external beam radiation therapy course.

Several issues arise with use of external beam radiation therapy. First, an optimal dose fraction schedule has not been well- established. The most common prescribed dose is 30 grays (Gy) in ten fractions. However, in Radiation Therapy Oncology Group (RTOG) 9714, investigators found no difference between 8Gy in single fraction versus extended 30Gy in 10 fraction schedule in terms of pain relief and narcotic medication usage at three months. Furthermore, an extended radiotherapy course can lead to patient inconvenience, longer hospitalization, and increased toxicity. In the RTOG 9714 trial, patients in the 30-Gy arm had more grade 2-4 toxicities than 8-Gy arm. Furthermore, there is a risk of vertebral fracture for patients treated with radiation therapy for spinal metastases. Researchers reported 31% of their patients with spinal cord compression treated with radiotherapy alone had vertebral collapse.

Hence, to achieve an optimal treatment option for symptomatic cancer patients with spinal metastases, the next logical step would be to combine stabilization (kyphoplasty) technique with direct tumor cell destruction in order to achieve maximum and durable pain palliation, prevent potential neurological dysfunction, and improve quality of life. By combining kyphoplasty with intraoperative radiation, one can achieve the above mentioned goals in a single outpatient procedure.

Combination of Kyphoplasty and Intraoperative Radiation:

During a surgical procedure, the tumor bed and/or the tumor itself can be irradiated with a single dose of radiation. Intraoperative radiation therapy \[IORT\] is the delivery of radiation during a surgical intervention. The advantages of the IORT consist of the high precision combined with optimal protection of the surrounding organs at risk. Hence, a higher dose of radiation can be applied to the target (as compared to external beam), while minimizing the adverse side effects to normal tissue. Furthermore, the single dose corresponds to at least two to three time times higher biological effective dose than conventional fractionated external beam radiotherapy. Another potential advantage is the prevention of tumor cell proliferation during the post-operative period prior to start of adjuvant radiotherapy.

In this study, the investigators will use low energy x-rays (photons) to treat spine lesions during kyphoplasty. The IORT device used will be the Intrabeam®, which is a miniature X-ray generator that produces low-energy X-rays: electrons are accelerated with a voltage of 30-50 kilovolts (kV) and hit a gold target at the tip of the drift tube. At this point the low-energy radiation is generated and emitted isotropically, similar to a point source. Due to its sharp dose fall off, minimal radiation protection is required in the operating room. The ultimate goal is to treat tumor cells with optimal sparing of spinal cord. (Please refer to Section 2.4 for more information on Intrabeam®).

Researchers at the University Medical Center in Mannheim, Germany completed a phase I trial assessing the tolerability of the Kypho-IORT procedure. Investigators reported their experience on performing the Kypho-IORT procedure in 18 patients (twenty-one vertebral lesions) with unstable or painful spinal metastases. The researchers used Intrabeam® to deliver 8Gy at 5mm distance from the spinal applicator surface using 50kV x-rays. The median age was 63 years and median follow up was 4.5 months (range, 1-10 months).

The procedure was well-tolerated. The median surgical time was 70 minutes (range, 53-173 minutes), which included radiation delivery time of approximately two minutes. Of the 21 vertebral lesions, 18 were treated successfully (86%). During the procedure, 78% of patients were noted to have asymptomatic paravertebral para-methoxymethamphetamine (PMMA) cement leakage. None of the treated patients had delayed wound healing, spinal or nerve root compression, paresthesia, new neurological deficit, or skin toxicity.

In terms of pain relief, the median visual analog pain score (VAS) was 5 prior to procedure. The VAS decreased to 2.5 on the first post-procedure day. At six weeks, 12 of the 18 patients were available to be evaluated and reported a median VAS score of 0/10. 67% of the patients required analgesic medication for pain relief prior to procedure, but decreased to just 30% at six weeks. Furthermore, imaging studies were available for 15 of the 18 patients, revealing 93% (14/15) patients had stable disease. Only one patient had progressive disease based on radiographic evidence, but this patient did not require any additional intervention.

INTRABEAM:

The Intrabeam® machine delivers low energy 50-kV photons directly to a target volume. The device generates electrons and then, accelerates them in a sealed vacuum probe (drift tube, measures 10 cm long and 3.2 mm in outer diameter). This drift tube, located within the x-ray spectrometer (XRS) unit, incorporates a gold target on the inside surface of its tip. When the accelerated electrons collide with the gold target at the end of the drift tube, photons are generated and dispersed in an isotropic dose distribution. The X-ray source itself is mounted on a balanced floor stand with six degrees of freedom to provide various treatment positions. The Intrabeam® system is calibrated for quality assurance prior to each treatment.

For the Kypho-IORT procedure, specially designed spinal applicator tip is used. This sterile applicator tip consists of a plastic head, which attaches to the drift tube and is then, placed inside a stainless steel tube (metallic sleeve). The applicator tip protects the drift tube from bending. The applicator is made of plastic in order to minimize the absorption and attenuation of the photons. Under fluoroscopic guidance, the applicator tip is guided though the metallic sleeves to the placed in mid-point/mid-plane of the vertebral lesion.

Due to the steep dose fall-off, a high dose to the vertebral lesion can be delivered, with maximum sparing of spinal cord. A radiation dose of 8 Gy at a distance of 5 mm from the applicator surface will be prescribed. This correlates to an approximate dose of 91 Gy at the applicator surface, 45 Gy at a distance of 1mm (from the applicator surface), 27Gy at 2mm, and 8Gy at 5mm. Further dose fall off is approximated: 2.4Gy at 10mm, 0.8Gy at 15mm, and 0.4Gy at 20mm. Assuming minimal distance of 15mm to the spinal cord, then, the spinal cord would receive less than 1Gy.

Study Design:

The combination of intraoperative radiotherapy with kyphoplasty will provide immediate vertebra stabilization, durable pain relief, and sterilization of tumor cells in a single outpatient procedure. To this date, this procedure has not been performed in the United States. The investigators plan to conduct a phase I trial of Kypho-IORT at the Loyola University Medical Center.

Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases

Patient will rate the severity of pain on a numeric 0-10 scale with higher scores indicating more severe pain. Pain assessment will be done at baseline, day of the procedure, and during follow up visits for up to 52 weeks.

Patients will be classified at week 52 as having (1) disappearance of the treated lesion (i.e., complete response), (2) at least 30% decrease in the diameter of the treated lesion (i.e., partial response), (3) at least 20% increase in the diameter of the treated lesion (i.e., progressive disease), or (4) Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (i.e., stable disease).

Loyola University

Assistant Professor

Fractures, Compression

Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.

Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone.

Vertebral Augmentation with Balloon Kyphoplasty

Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s).

Non-surgical Treatment

Frank Vrionis, M.D.

The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.

This is a prospective single center study designed to compare balloon kyphoplasty to non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body compression fractures in multiple myeloma patients. Because of the pilot nature and the small sample size of the study, patient randomization will NOT be stratified. Patients with mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization either balloon kyphoplasty or non surgical management. Randomization assignments will be generated by computer and investigator notified once the patient enrolled.

The observational arm will be compared to each of the other two arms; control and intervention arm using the same outcome variables and statistical methods.

Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures

A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures

Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture)

Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture

Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months

Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months

Quality of life as assessed by the Functional Assessment of Cancer Treatment - General (FACT-G) questionnaire in all enrolled patients and Roland Morris disability questionnaire for spine disability

Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture

Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant

Prognostic ability of bone biomarkers for the prediction of vertebral events

H. Lee Moffitt Cancer Center and Research Institute

Neoplastic Cells, Circulating

Bone Diseases

A small fluid balloon will create a hole in the broken back bone where tumor is located. After balloon deflation and removal, hole is filled with medical cement.

Kyphoplasty

Medical cement will be injected into broken back bone.

Vertebroplasty

Removes tissue (soft tissue, bone tissue, or both, but this will vary from person to person), including all or part of the cancerous tumors in the area of the broken back bone(s).

Cavity SpineWand

Dawid Schellingerhout, MD

Phase 1 - Optimization Phase:

Primary Objective: The primary objective of Phase 1 of this study is to determine the time point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard vertebroplasty and Kyphoplasty procedures relative to baseline CTCB.

Phase 2 - Comparison Phase:

Primary Objective: The primary objective of Phase 2 of this study is to determine the change in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to compare the average change between treatment groups with and without the use of the Cavity SpineWand.

Secondary Objectives:

* To determine the change in self-reported pain level from baseline to post-treatment as measured using the visual analogue scale (VAS) for spine pain and to compare the average change in pain level between treatment groups.
* To determine the change in pain status from baseline to post-treatment as measured using the Brief Pain Inventory (BPI) and to compare the average change in pain status between treatment groups.
* To determine the change from baseline to post-treatment in the M.D. Anderson Cancer Center Symptom Inventory (MDASI) and to compare the average change between treatment groups.
* To determine the change from baseline to post-treatment in time to walk a 50-foot distance and to compare the average change between treatment groups.

Kyphoplasty and Vertebroplasty:

Kyphoplasty and vertebroplasty are types of surgery that are used to treat broken bones in the back, which may have been caused by cancer. Both procedures involve injecting a mixture of medical cement into the broken bone(s) in the back. The cement is designed to harden and become a permanent part of the bone, supporting the bone like an "internal cast" that brings it back to its original shape. The amount of cement will vary from person to person, but it could be, for example, anywhere from a fraction of a teaspoon to a full teaspoon.

The main difference between the 2 procedures is that kyphoplasty involves the use of a small medical type of balloon, and vertebroplasty does not use balloons. Vertebroplasty also uses a slightly smaller needle to inject the cement.

The Study Device:

The Cavity SpineWand is a rod-shaped surgical tool that is designed to use a type of energy called plasma in order to destroy tissue at lower temperatures than other surgical methods. This may help to lessen damage to other nearby tissue.

In this study, the Cavity SpineWand will be used to remove tissue (soft tissue, bone tissue, or both, but this will vary from person to person), including all or part of the cancerous tumors in the area of the broken bone(s). This is designed to make extra room for the cement to be injected, either during the vertebroplasty procedure or the kyphoplasty procedure.

Screening Tests:

Before you can receive treatment in this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. If you have had some of these tests done recently, they may not need to be repeated. This will be up to your study doctor. The following tests may be performed:

* Your medical history will be recorded.
* You will have a magnetic resonance imaging (MRI) scan and a computed tomography (CT) scan. These scans will show pictures of your broken back bone(s) and the tumor. Your doctor will use these pictures to plan your surgery.

Women who are able to have children must have a negative urine pregnancy test.

Doctors currently do not fully understand whether kyphoplasty or vertebroplasty is better for treating broken bones in the back. For this reason, and because this study involves randomly assigning participants to receive one or the other of these procedures, all participants must be eligible for both procedures in order to take part in this study.

Treatment Groups:

If you are found to be eligible to take part in the study, you will be assigned to a treatment group. In each phase of the study, there is an equal chance of being assigned to any of the treatment groups.

If you are one of the first 20 patients enrolled in the study, you will be enrolled in Phase 1. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Phase 1 Group 1 will receive vertebroplasty, and Phase 1 Group 2 will receive kyphoplasty.

If you are one of the next 60 patients to be enrolled, you will be enrolled in Phase 2. You will be randomly assigned (as in the toss of dice) to 1 of 4 groups. Phase 2 Group 1 will receive vertebroplasty, and Phase 2 Group 2 will receive vertebroplasty with the Cavity SpineWand. Phase 2 Group 3 will receive kyphoplasty, and Phase 2 Group 4 will receive kyphoplasty with the Cavity SpineWand.

Study Tests/Procedures Before Surgery:

Within about 2-4 weeks before surgery, you will have tests and procedures performed. If you had some of these tests done recently, they may not need to be repeated. The following procedures may be performed:

* Your medical history will be recorded.
* You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate).
* You will complete questionnaires that ask about the back pain and any drugs you are taking. In total, the questionnaires should take about 10-20 minutes to complete.
* You will be asked to walk 50 feet at your own pace while being timed to see how long it takes you. This is a routine test for comparing your walking function before and after surgery.

You will sign a separate consent form for surgery and the drugs used during surgery. These drugs include antibiotics to help lower the risk of infection, drugs to control pain, local anesthesia to make the area of your back where you are having surgery feel numb, and a sedative to make you feel relaxed and sleepy. The risks of these drugs will be explained to you in detail at that time.

Blood Test on the Day of Surgery:

On the day of surgery, blood (about 1 tablespoon) will be drawn. This blood will be compared with the blood that is drawn after surgery, to see when after surgery the most tumor cells are found in the blood.

Other Procedures Before Surgery:

As is standard for these types of surgery, special "bone" needles will be placed into the broken bone(s) in your back. X-rays will be used to guide the needles into a safe position. A biopsy of the tumor in your back bone will be collected to check the diagnosis of cancer. To collect a biopsy, a small amount of tumor tissue is withdrawn through the bone needle.

Surgical Procedures:

If you are in Phase 2 Group 2 or Phase 2 Group 4, the Cavity SpineWand will be used to remove a small amount of tissue immediately before the kyphoplasty or vertebroplasty procedure.

If you are in Phase 1 Group 2, Phase 2 Group 3, or Phase 2 Group 4, the kyphoplasty procedure will be done next. A small balloon will be placed into the area in your back where the tumor is located. Fluid will then be pumped through the tube in order to fill the balloon, which will create a hole in the back bone. After the balloon is deflated (closed) and removed, this hole will then be filled with cement. X-rays will be used to help place the cement safely.

If you are in Phase 1 Group 1, Phase 2 Group 1, or Phase 2 Group 2, the vertebroplasty procedure will be done next (instead of the kyphoplasty). Cement will be injected into the back bone. X-rays will be used to help place the cement safely.

No matter which treatment group you are in, if you have more than 1 broken back bone that needs treatment, the procedures described above will be repeated for a second broken bone, right after your first procedure. In other words, if you had vertebroplasty performed without the Cavity Spine Wand, that same procedure would be performed for the second bone. The procedure would only be repeated this 1 additional time, and not a third time.

No matter which treatment you receive, the entire procedure should take about 2-3 hours. If you need to have the procedure repeated on a second broken bone, this additional procedure should add about 45 minutes to the 2-3 hours that the first procedure alone would have taken.

Blood Testing for Phase 1 Participants:

Phase 1 participants will have blood (about 1 tablespoon each time) drawn at 8 different times points in order to measure the number of tumor cells. This blood will be drawn at 10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery.

Blood Testing for Phase 2 Participants:

Phase 2 participants will have blood (about 1 tablespoon each time) drawn at 4 different time points after surgery. The first and second blood draw will occur before 36 hours has passed. The third blood draw will be about 36 hours after the surgery, and the fourth blood draw will be about 7 days after the surgery. This blood will be tested to measure the number of tumor cells.

Follow-Up Care:

You will be asked to return for follow-up visits at 7 days after your surgery and again at 4 weeks after your surgery. At these visits, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of vital signs.
* You will complete the questionnaires that ask about the back pain and any drugs you are taking.
* You will be asked to walk a 50-foot distance, and your walk will be timed.
* At the Day 7 visit only, blood (about 1 tablespoon) will be drawn to measure the number of tumor cells.
* At the Week 4 visit only, you will be asked to complete a questionnaire that asks you to rate how satisfied you feel with the surgery. It should take about 10 minutes to complete.

At 3 months after your surgery, the study staff will call you at home to ask about the back pain and any drugs you may be taking.

Length of Study Participation:

After the Month 3 follow-up phone call, your active participation in this study will be over. If it is determined after your surgery that the tumor in your back was not cancerous, you would still return for the follow-up visits as is standard, but you would not need to have the Day 7 blood test to measure the number of tumor cells.

This is an investigational study. The vertebroplasty and kyphoplasty procedures are commercially available and FDA approved for the way they are being used in this study. The Cavity SpineWand is also commercially available and FDA approved for the way it is being used in this study. The research-specific part of this study is the blood testing to measure any increases in the number of cancer cells in the blood.

Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.

Anderson Circulating Tumor Cell Burden (CTCB) Study

Assessment of Circulating Tumor Cell Burden After Radiofrequency-Based Plasma Ablation (COBLATION®) in Conjunction With Vertebroplasty or Kyphoplasty for Augmenting Painful Vertebral Compression Fractures Secondary to Malignancy

Increase in number of cancer cells in patient's blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).

ArthroCare Corporation

M.D. Anderson Cancer Center

No patients were enrolled in other groups or Phase II.

Phase 1 Group 1 Vertebroplasty

Phase 1 Group 2 Kyphoplasty

Phase 2 Group 1 Vertebroplasty

Phase 2 Group 2 Vertebroplasty +Cavity SpineWand

Phase 2 Group 3 Kyphoplasty

Phase 2 Group 4 Kyphoplasty + Cavity SpineWand

United States

Region of Enrollment

Dawid Schellingerhout, MD/Asst. Professor

Study terminated by sponsor; No data analysis done on limited amount of data gathered.

Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)

Phase 2: Change in CTCB From Baseline to Post-treatment

intraoperative radiotherapy (8 Gy) during kyphoplasty for spinal metatsases

intraoperative radiotherapy

Vertebral column is the most prevalent location of bone metastases. Besides axial pain, vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord compression. Although the median overall survival of patients with bone metastases is only 7-9 month, half of them live longer and will require palliative treatment for their symptoms.

Treatment options are radiotherapy and /or surgical treatment such as laminectomy, vertebroplasty or kyphoplasty. Various studies have shown the superiority of postoperative external beam radiotherapy after kyphoplasty in spinal metastases compared to surgery or radiotherapy alone. Nevertheless postoperative radiation schedules last 2-4 weeks. Moreover many patients present visceral and bone metastases simultaneously and require urgent systemic therapy. However, due to potentiated toxicity, concurrent therapy with full dose chemotherapy and radiotherapy is rarely possible.

The investigators have therefore established a novel method for intraoperative radiotherapy (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis and immediate initiation of chemotherapy.

The kyphoplasty itself is performed according to the standard procedure with some minor modifications. In short under general anaesthesia, a bipedicular approach into the affected vertebra is chosen with insertion of specially designed metallic sleeves to guide the electron drift tube of the miniature X-ray generator (INTRABEAM®). To perform the IORT during a kyphoplasty with this device a new applicator was designed. This sterile applicator consists of a plastic head, which is needed to attach it to the X-ray source and a stainless steel tube. This tube protects the probe from bending. Under fluoroscopic guidance the applicator including the drift tube is guided through the metallic sleeves in the vertebral body. A dose of 8 Gy in 5 mm distance is delivered. After IORT the INTRABEAM system is removed. The kyphoplasty balloon is inflated and PMMA-cement is injected. Afterwards the sleeves are removed and the wound is closed as usual.

Aim of this study is the definition of the maximum tolerable dose (MTD) for IORT during a kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined treatment procedure. To determine the MTD 3 levels with increasing doses are planned:

8 Gy in 5 mm distance, 8 Gy in 8 mm distance and 8 Gy in 10 mm distance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Health-Related Quality of Life (QOL), Physical and Respiratory Function in Patients With Myeloma Affecting the Spine	NCT01006070	Multiple Myelom...	kyphoplasty	-	University of California, San Francisco
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)	NCT02225223	Metastatic Lesi...	STAR™ Tumor Abl... StabiliT® Verte...	18 Years -	Merit Medical Systems, Inc.
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study	NCT02987153	Spinal Metastas...	Kypho-IORT	18 Years -	Northwell Health
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases	NCT00374751	Cancer Metastasis Pain	Samarium (153SM...	18 Years - 80 Years	New York Presbyterian Brooklyn Methodist Hospital
Health-Related Quality of Life (QOL), Physical and Respiratory Function in Patients With Myeloma Affecting the Spine	NCT01006070	Multiple Myelom...	kyphoplasty	-	University of California, San Francisco
Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases	NCT02480036	Spinal Metastas...	IORT with Kypho... Intrabeam®	50 Years -	Loyola University
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)	NCT02225223	Metastatic Lesi...	STAR™ Tumor Abl... StabiliT® Verte...	18 Years -	Merit Medical Systems, Inc.
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases	NCT00374751	Cancer Metastasis Pain	Samarium (153SM...	18 Years - 80 Years	New York Presbyterian Brooklyn Methodist Hospital
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures	NCT01175278	Multiple Myelom...	Vertebral Augme... Non-surgical Tr...	21 Years -	H. Lee Moffitt Cancer Center and Research Institute
Anderson Circulating Tumor Cell Burden (CTCB) Study	NCT00819832	Cancer Spinal Disease Vertebral Compr...	Kyphoplasty Vertebroplasty Cavity SpineWan...	18 Years -	M.D. Anderson Cancer Center
Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases	NCT01280032	Tumors	intraoperative ...	50 Years -	Universitätsmedizin Mannheim

Spots Global Cancer Trial Database for kyphoplasty

Every month we try and update this database with for kyphoplasty cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kyphoplasty

Every month we try and update this database with for kyphoplasty cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kyphoplasty cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.