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ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain | Clinical Trials | Clareo Health

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ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic and Multiple Myeloma Bone Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation Therapy

NCT00656305•InSightec

View on ClinicalTrials.gov

Summary

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women age 18 and older
•2. Patients who are able and willing to give consent and able to attend all study visits
•3. Patients who are suffering from symptoms of bone metastases or multiple myeloma bone lesions and are radiation failure patients:
•Radiation failure candidates are those who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy,
•4. Patients who refuse other accepted available treatments such as surgery or narcotics for pain alleviation.
•5. Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication
•6. Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)
•7. Targeted tumor (treated) size up to 55 cm2 in surface area
•8. Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
•9. Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
+11 more criteria

Exclusion Criteria

•1. Patients who either
•* Need surgical stabilization of the affected bony structure (\>7 fracture risk score, see Section 7.3) OR
•* Targeted tumor is at an impending fracture site (\>7 on fracture risk score, see Section 7.3).
•OR
•\- Patients with surgical stabilization of tumor site with metallic hardware
•2. More than 5 painful lesions, or more than 1 requiring immediate localized treatment
•3. Targeted (treated) tumor is in the skull
•4. Patients on dialysis
•5. Patients with life expectancy \< 3-Months
•6. patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
+22 more criteria

Locations (14)

University of California San Diego

La Jolla, California, United States

Stanford University Medical Center

Stanford, California, United States

University MRI & Diagnostic Imaging Centers

Boca Raton, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Weill Cornell Medical College

New York, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Toronto General Hospital

Toronto, Ontario, Canada

Rambam medical Center -The Pain palliation unit

Haifa, Israel

Key Dates

Start Date

March 1, 2008

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

February 5, 2020

Enrollment

147

ACTUAL participants

Conditions

Bone MetastasesMultiple Myeloma

Interventions

ExAblate MRfFUS

DEVICE

Sham

DEVICE

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

NCT06179888

Multiple Myeloma

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RECRUITINGPHASE3

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

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RECRUITINGPHASE1/PHASE2

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain

Inclusion Criteria

Exclusion Criteria

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Elranatamab in R/R Multiple Myeloma