Status:
WITHDRAWN
MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases
Lead Sponsor:
Stanford University
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of pa...
Detailed Description
The primary purpose of this study is to see if MR guided high intensity focused ultrasound (MR-HIFU) treats bone pain faster than the standard radiation therapy (External beam radiation therapy: EBRT)...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Painful metastatic bone lesions, with NRS \> 4 documented at screening visit
- Pain from target lesion is distinguishable from other lesions\*
- Target lesion lovation is accessible for MR-HIFU and EBRT\*\*
- Target lesion is visible om MR or CT imaging obtained \< 3 months prior to screening, with a maximum diameter of 8 cm.
- Reasonable performance score (KPS \> 50% or ECOG \<3)
- Life expectancy \> 3 months as determined by the study PI or referring oncologist
- Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
- Solitary painful metastatic bone lesion or multiple metastatic lesions with one predominantly painful target lesion (≥2 points higher pain score than other lesions).
- e.g.: Extremities, pelvis (os pubis, os ilium, os ischium, sacrum, acetabulum), shoulders, in selected cases ribs and sternum
Exclusion
- Previous surgery, radiation, HIFU, or other local therapy on the target location
- Neurological symptoms due to nerve involvement of target lesion
- Need for surgery of targeted location due to (impending) pathological fracture
- Unavoidable critical structures or dense tissues in target area\*
- Curative intention of treatment plan
- Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI - safe, size limitations, claustrophobia, etc.
- Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR \<30mL/min/1.73 m\^2) or on dialysis
- Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- Patients unable to receive general anesthesia, as determinded by anesthesiologist, study PI or referring oncologist
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time) via self report
- Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
- Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
- as judged by the operator. e.g.: nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g. hollow viscera), (external) fixation device
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05250687
Start Date
June 1 2024
End Date
December 1 2024
Last Update
October 1 2024
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94306