Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With th… (NCT01085565) | Clinical Trial Compass
CompletedPhase 2
Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
Israel50 participantsStarted 2010-03
Plain-language summary
The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.
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 age 18 and older
. Patients who are able and willing to give consent and able to attend all study visits
. Patients who are suffering from symptoms of bone metastases
. Targeted tumor(s) are ExAblate device accessible and 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)
. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors irrespective of medication.
. Patient who's targeted tumors are on bone and bone-lesion interface is more than 1cm from the skin, major nerve or hollow viscera.
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.