Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU (NCT05167669) | Clinical Trial Compass
CompletedNot Applicable
Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU
Switzerland10 participantsStarted 2022-10-01
Plain-language summary
Metastatic disease to the bone is a common cause of pain. External beam radiation therapy (EBRT) is the standard palliative treatment BUT pain improvement is observed in 60% to 80%. Combination of hyperthermia (HT) with radiation is strongly compelling. MR is providing accurate, tissue-independent thermometry for intra-procedural guidance of thermal therapy. In this project we aim to combine in an adjuvant setting mild hyperthermia to EBRT for sustained relief of pain in patients with symptomatic bone metastases.
Who can participate
Age range
18 Months
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:
* • Histologically proven cancer;
* cancer-related pain corresponding to a site (or sites) of radiologically confirmed bone metastases with a severity score of at least 2 out of 10 according to the Brief Pain Inventory (NRS scale);
* age ≥ 18 years;
* indication for a palliative course of EBRT;
* osteolytic or mixed (osteoblastic/osteolytic) bone metastases ≤ 5 cm in the largest diameter; target tumours accessibility for device (ribs, extremities, pelvis, shoulders or posterior aspects of spinal vertebra) and at least 1 cm from skin and major nerve bundles;
Exclusion Criteria:
* Inability to provide a written informed consent;
* Karnofsky performance status (KPS) \< 60; presence of clinical or radiological evidence of spinal cord compression, a pathological fracture, or an impending fracture needing surgical fixation;
* previous EBRT to study site (or sites);
* participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry;
* inability to comply with study and follow up procedures;
* patients having metal implants, pacemakers or clustered markers non-MR compatible
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
Accurate elevation of temperature measured by MRI thermometry (degree celsius)
Timeframe: day 1
2
Safety and patient tolerance according to The adverse events (CTCAE v5.0) (Art. 2 Abs 58 MDR)