Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRg… (NCT01091883) | Clinical Trial Compass
CompletedNot Applicable
Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma
Taiwan60 participantsStarted 2010-05
Plain-language summary
The goal of this study is to collect comparative data on safety and efficacy of MR Guided Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or multiple myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women age 18 years and older.
✓. Able and willing to give consent and to attend all study visits
✓. Patients with bone metastasis or primary bone lesion identifiable by imaging techniques.
✓. Worst NRS Pain Score of ≥ 4 from the tumor to be treated.
✓. Targeted tumor(s) are accessible to both ExAblate and EBRT (ExAblate accessible lesions 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), please see ExAblate "Information for Prescribers".
✓. Targeted tumor(s) area is smaller than 100cm2.
✓. Tumor(s) clearly visible by non-contrast MRI.
✓. No radiation therapy to the treated lesion during one month prior to enrollment.
Exclusion criteria
✕. Patients who either
✕. Targeted tumor is in a vertebra body or in the posterior aspects of the cervical part of the vertebral column.
✕. Targeted tumor is in the skull.
✕. Patients on anti-coagulation therapy or with an underlying uncontrolled bleeding disorder.