MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease (NCT03404362) | Clinical Trial Compass
CompletedNot Applicable
MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease
Italy198 participantsStarted 2017-01
Plain-language summary
The objective of this trial is to collect and compare safety and effectiveness data of Magnetic Resonance guided Focused Ultrasound (MRgFUS) using the ExAblate 2100 device and radiotherapy in the treatment of metastatic bone tumors.
This study is designed as a prospective, double arm, non-randomized study with External Beam radiation therapy (EBRT) serving as control arm.
The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT.
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.
✓. Each targeted tumor is 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 area is smaller than 100cm2.
✓. Tumor clearly visible by non-contrast MRI.
✓. No radiation therapy to selected lesion during one month prior to enrollment.
Exclusion criteria
✕. Patients who either need pre-treatment surgical stabilization of the affected bony structure
What they're measuring
1
Determine the effect of MRgFUS in terms of level of pain relief and decrease in analgesics/opiate and improved quality of life.
✕. Targeted tumor is in a vertebra body or in the posterior aspects of the vertebral column other than Lumbar vertebra (L3 - L5) and Sacral vertebra (S1 - S5).
✕. Targeted tumor is in the skull.
✕. Patients on anti-coagulation therapy or with an underlying uncontrolled bleeding disorder.
✕. Patients with life expectancy \< 6-Months.
✕. Patients with unstable cardiac status including:
✕. Severe hypertension (diastolic BP \> 100 on medication).
✕. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted ferromagnetic objects/devices.