Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Fractures, Bone

Bone Marrow Diseases

Spinal Fractures

Fractures, Compression

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Neoplastic Processes

Spinal Injuries

Back Injuries

A bilateral approach is chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach.Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity.The balloons are then deflated and removed. The Bone Filler Device is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula.

balloon kyphoplasty

Jean-Denis LAREDO, M.D.,PR.

Antoine FEYDY, M.D., PhD

Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications.

This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure.

Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.

The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.

Vertebral compression fractures (VCF) represent an important source of morbidity in patients presenting osteolytic metastatic or myelomatous vertebral involvement. In addition, cancer treatments may induce osteoporosis with an additional risk of vertebral fractures.

* Current medical treatments are symptomatic. They do not treat the fracture itself.
* Vertebroplasty is an interventional radiological technique that consists of injecting, percutaneously, acrylic cement into the fractured vertebra under radiological guidance and local or general anaesthesia, in order to combine two effects: stabilization of the vertebral body fracture and pain reduction.
* Balloon Kyphoplasty is a variant of vertebroplasty which is performed using the KyphX® System (Medtronic., Sunnyvale, California). Balloon kyphoplasty aims at restore vertebral height of the fractured vertebra using an inflatable balloon prior to inject surgical polymethylmetacrylate (PMMA)cement,into the vertebral body to fix the fracture. It is an expensive technique costing around 4,000 euros for up to 2 vertebrae in the same patient. The surgical technique for the procedure has been described by LIBERMEAN et al: A bilateral approach is usually chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach. In case of limited and asymmetric vertebral destruction, a single unilateral approach may be preferred. Fluoroscopy is used to insert the tools and control the procedure. With reaming tools, two working channels are created and the balloons are inserted. The balloons are available in lengths of 10, 15 and 20 mm.

The two balloons (one on each side) should ideally be centered at middle height between the superior and inferior endplates and in the anterior two-thirds of the vertebral body. Balloon placement into the vertebral body is checked using radiopaque markers at the two extremities of the balloon. Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity. Inflation is stopped when one of the following inflation endpoints is reached: pressure raised over 400 psi, balloon contacts one of the cortical bone of the vertebra or reaching maximal balloon inflation volume. The balloons are then deflated and removed. The mean balloon inflation volume is 2 to 3ml. The Bone Filler Device, filled before with 1.5 ml of PMMA, is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula. This step is repeated till a complete fill of the cavity is obtained. The same procedure is repeated through the other working cannula at the contra-lateral pedicle. Filling of the cavity with highly viscous PMMA is performed under continuous fluoroscopic control.

The aim of this study is to quantify the analgesic and patient function improvement of Balloon Kyphoplasty together with complication types and rate in patients with malignant vertebral fractures due to metastatic disease or multiple myeloma.

Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.

Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"

Assistance Publique - Hôpitaux de Paris

Dermatologic Agents

All Drugs and Chemicals

Verteporfin

Photosensitizing Agents

Visudyne

An estimated 10 percent of primary breast, prostate, lung, thyroid and renal cell tumors metastasize to the spine. The majority of these tumors are detected before surgical intervention is required and most patients receive radiation therapy for symptomatic relief. Complete pain control, duration of pain control, high recurrence rates and soft tissue complications make radiation a less than ideal treatment. Also, pre-operative radiation therapy is a significant negative predictor for surgical outcomes. To improve the treatment options for patients with advanced cancer with spinal lesions the research team investigated a new minimally invasive therapy known as photodynamic therapy (PDT) that targets metastatic spine lesions with limited side effects. PDT involves the use of a photo-activated chemotherapeutic agent, given intravenously that when stimulated by non-thermal wavelength-specific light allows for selective ablation of tumor tissue. The light is delivered to the spine through small fiber optic cables using a diode laser. By combining canine and porcine studies the investigators have strong evidence to support that PDT is both safe and effective for the treatment of metastatic tumors in the spine. PDT is targeted, repeatable, minimally invasive and has limited local and systemic side effects. Its use would enhance the treatment options for patients with advanced stage cancer. The goal of the present study is to demonstrate that PDT can be safely and effectively given to treat spinal metastases in patients with advanced stage cancer who have multiple lesions or who have failed radiation or surgical intervention. The effectiveness of this treatment will be determined through clinical and radiographic endpoints along with recurrence and survival. The investigators intend to demonstrate that PDT is a minimally invasive method with low morbidity and mortality by which spinal tumors can be ablated and later stabilized through vertebroplasty, optimizing quality of life and providing effective treatment.

There are over 1.5 million cases of cancer reported each year in North America and a significant number of patients eventually suffer from metastases to the spine which present as an extremely challenging problem for both the clinician and patient. Primary tumors that most commonly affect the spine include breast, prostate, lung, thyroid and renal cell cancer. Estimates from large clinical series report at least a 10 percent rate of metastases to the spine from these most common tumors. These lesions are extremely painful and significantly affect the quality of life of advanced stage cancer patients. The majority of these tumors are detected before surgical intervention is required and most patients receive radiation therapy for their spine lesions for symptomatic relief. However, complete pain control, duration of pain control along with a high recurrence rate of lesions and soft tissue complications makes radiation a less than an ideal treatment. In addition, pre-operative radiation therapy is a significant negative prognosticator for surgical outcomes.

To improve the treatment options for patients with advanced cancer with spinal lesions the research team has investigated a new minimally invasive therapy, known as photodynamic therapy (PDT) that targets metastatic spine lesions directly and has limited side effects. PDT involves the use of a photo-activated chemotherapeutic agent, benzoporphyrin derivative (verteporfin/Visudyne) given intravenously that when stimulated by non-thermal wavelength-specific light allows for selective ablation of tumor tissue. The light is delivered to the spine through small fiber optic cables (outer diameter 0.98mm, inner core of 0.5mm mm) using a diode laser. Visudyne is an FDA and Health Canada approved photosensitizer that has been used in over one million patients for the treatment of age related macular degeneration, a leading cause of blindness in the elderly. To investigate the use of PDT for spinal metastases the investigators initially developed a bioluminescent metastatic rodent model using human breast cancer that metastasized to the spine. Using this model it was determined that PDT was effective at treating metastatic breast cancer lesions in the spine. The research team next utilized non-tumor bearing canine and porcine models to determine that the treatment could be safely delivered to the spine and conduct light dosimetry analysis. The safety of PDT intra-operatively was assessed using somatosensory evoked potentials and through post-treatment clinical examination and magnetic resonance imaging (MRI). The effects PDT had on the spine were analyzed by comparing pre-operative and post-operative MR imaging and correlating those in turn with histological analysis. None of these animals suffered weakness or complication from the use of PDT around the spinal cord. During these studies the investigators developed the planning, delivery and instrumentation methodologies to deliver PDT to spinal tumors and the methodology to combine this therapy with vertebroplasty, a percutaneous method of stabilizing the spine. In addition, in a separate set of studies, highgrade osteosarcomas in canines were treated to determine the effect PDT had on large bone tumors. The results of this study again provided comparison of pre and post-treatment effects seen on MRI and histological analysis. The volume of effect seen in the osteosarcomas was up to 25cm (cubed) and was comparable to the volume of effect required for complete treatment of spinal lesions. By combining the canine and porcine studies there is strong evidence that PDT is both safe and effective for the treatment of metastatic tumors in the spine.

PDT has many advantages over current therapies; it is targeted, repeatable, minimally invasive and has limited local and systemic side effects. Its use would enhance the treatment options for patients with advanced stage cancer. The goal of the present study is to demonstrate that PDT can be safely and effectively given to treat spinal metastases in patients with advanced stage cancer. The study is a pilot study and will determine the safe and accurate treatment of 30 patients with spinal metastases who have multiple lesions or who have failed radiation or surgical intervention. The effectiveness of this treatment will be determined through clinical and radiographic endpoints with recurrence and survival also determined. The investigators intend to demonstrate that PDT provides a minimally invasive method with low morbidity and mortality by which spinal tumors can be ablated and later stabilized through vertebroplasty, optimizing quality of life and providing effective treatment for this devastating manifestation of advanced stage cancer.

Photodynamic Therapy for the Treatment of Vertebral Metastases

Photodynamic Therapy (PDT) for the Treatment of Vertebral Metastases: A Prospective Phase I Clinical Trial

The analgesic effect of surgical treatment will be estimated using the SF-36

The analgesic effect of surgical treatment will be estimated using the visual analogue (VAS) pain scale.

Intraoperative dosimetry data on light transmission and attenuation in patient specific diseased bone will be contrasted to pre-operative imaging data and the region of effect based on actual light transmission compared to pre-operative planning algorithms. These results will gauge the potential accuracy of our planning algorithms.

The primary safety parameter will be unexpected worsening in neurological function.

Physical examination will include a detailed neurological examination (including ASIA score) that assesses the strength, sensation and reflexes of the patient in the upper and lower extremities

Sunnybrook Health Sciences Centre

Orthopaedic Surgeon

Musculoskeletal Diseases

Hemorrhage

Blood Loss, Surgical

Spinal Neoplasms

Neoplasms, Second Primary

32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.

Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

Arteriography and preoperative embolization

Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.

Arteriography

Lars Lönn, MD, Ph.d.

The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.

Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.

Defined as the amount of time (measured in minutes) from skin incision to skin closure.

Rigshospitalet, Denmark

Selected patients with spine metastases are treated with ablative single dose SBRT and VMAT technique in various solid tumors .

One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.

Single dose SBRT and VMAT technique

Ciro Franzese, MD

Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.

This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites.

The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.

Study of Image-Guided SBRT for Vertebral Metastases

Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases

Istituto Clinico Humanitas

Recurrence

Pain

Neoplasm, Residual

Neoplasm Recurrence, Local

Disease Attributes

Depending on the modified Mizumoto Score (0-4 points or 5-9 points) patients will be treated with 10 fractions of 4.85Gy in involved parts of the vertebra and 3Gy in not-involved parts using a simultaneous integrated boost or with 5 fractions of 7Gy in involved parts of the vertebra and 4Gy in not-involved parts using a simultaneous integrated boost, respectively.

Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery

Radiosurgery

Matthias Guckenberger, MD

It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this II trial.

The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study.

1. A prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety.
2. Fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. Fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment.
3. Dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept.

Evaluation of the single intervention - dose-intensified SBRT

Fractionated Radiosurgery for Painful Spinal Metastases

Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)

Decrease in pain by ≥2 points at the treated vertebral site on the 0 (no pain) to 10 (the severest pain) Visual Analogue Scale without analgesic increase

At the treated vertebral levels assessed with MRI

At the treated vertebral levels assessed with CT imaging

Measured with the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems) EuroQol 5-Dimension Questionnaire (EQ-5D) questionnaire

Measured with the EuroQol Visual Analog Scale from 0 ("the worst health you can imagine") to 100 (the best health you can imagine")

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.	NCT00748631	Vertebral Fract... Multiple Myelom... Osteolytic Meta...	balloon kyphopl...	18 Years -	Assistance Publique - Hôpitaux de Paris
Photodynamic Therapy for the Treatment of Vertebral Metastases	NCT02464761	Vertebral Metas...	Visudyne	20 Years - 85 Years	Sunnybrook Health Sciences Centre
Preoperative Embolization in Surgical Treatment of Spinal Metastases.	NCT01365715	Spinal Metastas...	Arteriography a... Arteriography	18 Years -	Rigshospitalet, Denmark
Study of Image-Guided SBRT for Vertebral Metastases	NCT02616887	Vertebral Metas...	Single dose SBR...	18 Years -	Istituto Clinico Humanitas
Fractionated Radiosurgery for Painful Spinal Metastases	NCT01594892	Neoplasm Metast... Neoplastic Proc... Neoplasm Recurr... Neoplasm, Resid... Pain	Radiosurgery	19 Years -	Wuerzburg University Hospital

Spots Global Cancer Trial Database for vertebral metastases