Clinical trial · Interventional
Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
- 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)
Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. There is also evidence that a high intensity focused ultrasound beam can penetrate through the cortical bone to the medullary space, producing thermal necrosis of cancer tissue. However, little is known about the potential effects of MRgFUS as first line therapeutic modality for pain palliation in skeletal metastases. Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of painful bone metastases and determine the potential of this technique for local tumor control.
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 |
|---|---|---|---|
| MRgFUS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRgFUS
- description
- High intensity focused ultrasound energy, delivered under the guidance of the MR images (MgFUS) allows for a predefined amount of energy to be delivered in the desired target (Metastasis). Bone readily absorbs focused ultrasound energy resulting in a thermo-related neurolysis of the periostium with consequent pain palliation. The amount of energy delivered can be modulated with the objective to penetrate cortical space and obtain necrosis of the metastasis thus preventing local recurrence.
- interventionNames
- Procedure: MRgFUS
Primary outcomes (1)
- measure
- To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases
- timeFrame
- 6 months
- description
- Patients will be monitored for major or minor adverse events
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * the presence of a known primary cancer and bone metastases confirmed by two or more imaging modalities; * exhaustion or refusal of all other pain palliation methods including EBRT; * confirmation of MRgFUS treatment feasibility at a preliminary MR planning examination (presence of an adequate acoustic window between the transducer, skin and target lesion and absence of bowel loops across the planned ultrasound path) Exclusion Criteria: * general contraindication to MR imaging (including pacemaker, ferromagnetic devices or implants) * general contraindication to gadolinium-based contrast agents (intolerance and/or clinically proven chronic renal failure) * general contraindication to general/epidural anesthesia or deep sedation
References
Publications (0)
Data not yet available