Status:
COMPLETED
MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Secondary Bone Cancer
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 trea...
Detailed Description
This is a prospective, phase II, open-label, non-randomized, double arm study to collect data on safety and effectiveness of ExAblate MRgFUS and EBRT treatments of metastatic bone tumors. Following tr...
Eligibility Criteria
Inclusion
- 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.
- Radiation therapy to selected lesion is not contraindicated
- Bisphosphonate, chemo or hormone therapy intake should remain stable throughout follow up duration.
Exclusion
- Patients who either need pre-treatment surgical stabilization of the affected bony structure
- 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:
- Unstable angina pectoris on medication.
- Patients with documented myocardial infarction within last 40 days to protocol entry.
- Congestive heart failure NYHA Class IV
- Severe hypertension (diastolic BP \> 100 on medication).
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted ferromagnetic objects/devices.
- Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist)
- KPS score of below 60
- Severe cerebro-vascular disease (multiple CVA or CVA within 6 months)
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
- Target tumor is less then 1cm from spinal cord, skin, or hollow viscera.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT03404362
Start Date
January 1 2017
End Date
September 1 2020
Last Update
February 17 2022
Active Locations (2)
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1
Alessandro Napoli
Rome, Italy, 00100
2
Sapienza University of Rome, Policlinico Umberto I Hospital
Rome, Italy