MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases (NCT05250687) | Clinical Trial Compass
WithdrawnNot Applicable
MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases
Stopped: Insigthec is no longer seeking support of the device used for this clinical trial
United States0Started 2024-06
Plain-language 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 painful bone metastases.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Previous surgery, radiation, HIFU, or other local therapy on the target location
. Neurological symptoms due to nerve involvement of target lesion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants that achieve a complete response (CR) or partial response (PR)
. 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