Clinical trial · Interventional
Pilot Study for Palliation of Pain in Bone Metastases by MR-HIFU
Pilot Study for the Treatment of Bone Metastases by High Intensity Focused Ultrasound Guided by MRI to Perform Pain Palliation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to confirm the safety and technical of MRI guided High Intensity Focused Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue. The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Secondary Malignant Neoplasm of Bone | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity Focused Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treated bone metastasis
- description
- Patients with bone metastasis causing pain.
- interventionNames
- Device: High Intensity Focused Ultrasound
Primary outcomes (3)
- measure
- Technical efficacy by medication and pain score
- timeFrame
- 0, 2, 7, 14, 30, 90 days
- description
- Technical efficacy of HIFU for treatment of bone metastasis as assessed by a change in the medication and pain scores
- measure
- Safety of treatment
- timeFrame
- 0-90 days
- description
- Safety of HIFU for treatment of the bone metastasis as determined by adverse event reporting
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women aged \> 18 years * Covered by social security insurance * Patient able to give consent and able to attend * study visit * Weight \< 140kg * Patient with bone metastases * Pain localized on bone metastases to be treated with NRS (0-10 scale) pain score 4 irrespective of medication * Targeted tumor accessible for MR-HIFU treatment * The maximum size of the bone metastases smaller than 8cm in diameter * Targeted tumor visible by non contrast MRI * Interface between bone and skin deeper than 10 mm * Able to communicate sensation during treatment * Treatment day must be planned at least 2 weeks after any treatment of the primary tumor, chemotherapy or RT treatment of a bone targeted for HIFU Exclusion Criteria: * Person subject to a judicial safeguard order, subject participating in another research study including an exclusion period which has not expired at the time of screening * Patient enrolled in another clinical study related to bone metastases or pain relief treatment * Pregnant or nursing woman * Need of surgical stabilization or site at risk of * fracture * More than one painful lesion per treatment * Patients who are not able to tolerate required stationary position during treatment * HIFU targeted tumor in contact with hollow viscera * Targeted tumor less than 1 cm to nerve bundles, bladder and bowel * Targeted tumor located in skull, spine (excepted sacrum) or sternum. * MRI or contrast agent contraindicated * Severe Cardiovascular, neurological, renal or hematological chronic disease * Active infection * Scar in the beam path * Orthopedic implant at the site of treatment * Previous surgery at the site of treatment Patient history, MRI exam * Primary musculoskeletal malignancies, lymphoma, or leukemia
References
Publications (1)
- BACKGROUNDChow E, Wu JS, Hoskin P, Coia LR, Bentzen SM, Blitzer PH. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002 Sep;64(3):275-80. doi: 10.1016/s0167-8140(02)00170-6. PMID 12242115