Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bo… (NCT04310410) | Clinical Trial Compass
CompletedPhase 1/2
Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis
Netherlands10 participantsStarted 2019-04-11
Plain-language summary
The PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria.
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:
* Men and women with age ≥ 18 years
* Patient capable of giving informed consent and able to attend study visits
* Uncomplicated painful bone metastases
* Weight \<140kg and able to fit in the MRI gantry
* Radiologic evidence of bone metastases from any solid tumor
* Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
* Pain related to the target lesion is refractory to less invasive treatments for pain relief
* Multiple metastatic lesions, with one predominantly painful lesion (\>=2 points higher pain score than other lesions). The lesion should be clearly distinguishable from other painful lesions.
* Device accessible tumors: extremities (excluding joints), pelvis, shoulders, posterior vertebral spine below L5, in selected cases ribs and sternum
* Target lesion maximum dimension ≤ 8cm
* Intended target volume visible by non-contrast MR imaging
* Distance between target and skin ≥ 1cm
* Numeric Rating Scale (NRS) score \>= 4 or equivalent
* Life expectancy \>3 months
Exclusion Criteria:
* Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
* Communication barrier present
* Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
* Unable to tolerate required stationary position during treatment despite adequate pain medication
* Need for surgery
* Pregnant woman
* Pain related to target lesion is predominan…
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
Feasibility of combined treatment with EBRT and MR-HIFU - Patient tolerance: questionnaire
Timeframe: 4 weeks
2
Feasibility of combined treatment with EBRT and MR-HIFU - hospital logistics