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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Prostatic Neoplasms

Kidney Diseases

Liver Diseases

Gastrointestinal Diseases

Genital Diseases, Female

Urogenital Diseases

Pancreatic Diseases

Esophageal Diseases

Genital Diseases

Male Urogenital Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Bone Diseases

FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery.

FloTrac Sensor + Vigileo Monitor only used for data collection during surgery; Standard of Care to decide fluid amount.

Study Group = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Control Group = Information from the monitor will be collected and compared to the information collected from participants in Study Group.

Vigileo Monitor

Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.

FloTrac Sensor

Gabriel Mena, MD

The purpose of this study is to determine whether the early identification and more precise intervention of operating room (OR) patient fluid administration optimization using arterial pressure-based cardiac output (APCO) yields comparable patient outcome as fluid administration optimization using a global standard care method.

THE EDWARDS VIGILEO MONITOR:

The Vigileo™ monitor measures the amount of blood the heart pumps through the body.

SCREENING TEST:

Before you can begin this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Women who are able to have children must have a negative urine pregnancy test.

STUDY GROUP:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to either the Control Group or the Study Group. You will have an equal chance of being assigned to either group. You will not know to which group you have been assigned.

STUDY PARTICIPATION:

You will have a arterial catheter (small plastic tube) inserted into an artery inside your wrist at the beginning of surgery. This is used routinely (even in patients not taking part in the study) to measure your blood pressure more accurately rather than with a blood pressure cuff. It is inserted after you receive general anesthesia (numbing medicine), so you should feel no pain. If it is inserted while you are awake (based on the judgment of your anesthesiologist), then local anesthesia will be given to you to reduce discomfort.

If your doctors decide that an arterial catheter is not required as part of your routine medical care during your surgery, they will not place one for study purposes only. In that situation, you will be removed from the study, and your medical care will continue as planned by your doctors.

If the catheter is placed, the Vigileo™ monitor will be connected to the catheter and readings will be taken during the surgery. It will be disconnected at the end of surgery.

If you are in the Study Group, your doctor will use the monitor and routine vital sign measurement to decide how much fluid to give you during surgery.

If you are in the Control Group, your doctor will not know the information being collected by the monitor, as it will be collected and compared to the information collected from participants in the Study Group. The amount of fluid you received during surgery will be decided by routine vital sign measurement, as is standard of care.

ESOPHAGEAL DOPPLER:

Regardless of study group assignment, during your surgery, researchers will also connect an esophageal doppler which will also collect data on fluid volume.

The esophageal doppler is a thin, tube-like device that is placed in your throat while you are asleep. This is used routinely by doctors to assist in the administration of fluids during surgery.

The information from the doppler will be compared to the information collected from the Vigileo™ monitor. The esophageal doppler measures blood flow through your heart by ultrasound waves.

LENGTH OF STUDY:

You will be considered off study once you leave the recovery room.

FOLLOW-UP:

Researchers will be collecting information on your progress during and after surgery, including when you are allowed to leave the hospital. Your medical records will be reviewed after surgery and up to 6 months after surgery to see how you are doing and if you have had any medical problems. The kind of information researchers will be collecting is the amount of time you were in the intensive care (if any), amount of time in the hospital, any complications or problems you may have had, how well you organs are functioning, and general health information.

This is an investigational study. The Vigileo™ Monitor and esophageal doppler are FDA approved and commercially available for volume monitoring. The comparison of the monitor and doppler is investigational.

Up to 218 patients will be enrolled in this multi-center study. Up to 66 will be enrolled at M.D. Anderson.

Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy

Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy

Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.

Edwards Lifesciences

M.D. Anderson Cancer Center

Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.

Overall Study

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Gabriel Mena, MD / Professor

Study terminated by sponsor without analysis due to technical reasons.

Length of Hospital Stay (LOS) by Participant

Symptoms and General Pathology

Neoplasm Metastasis

Pain

Neoplastic Cells, Circulating

Fractures, Compression

Neoplastic Processes

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

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

Total

Age, Continuous

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

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
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 Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy	NCT00526331	Esophageal Dise... Gastrointestina... Disorder of the... Gynecologic Dis... Kidney Diseases Liver Diseases Pancreatic Dise... Prostate Cancer Spinal Disease	Vigileo Monitor FloTrac Sensor	18 Years -	M.D. Anderson Cancer Center
Anderson Circulating Tumor Cell Burden (CTCB) Study	NCT00819832	Cancer Spinal Disease Vertebral Compr...	Kyphoplasty Vertebroplasty Cavity SpineWan...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for spinal disease