Clinical trial · Interventional
Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): CI of study retired on 6.10.2020 and there will be no further efforts to apply for an extension in order to recruit to this study.
Summary
Brief summary (as posted)
The primary objective of this study is to determine whether intra- and post-procedural MR changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort of patients with painful bone metastases, who wish to consider MRgHIFU treatment. These patients will be identified in conjunction with the pain and palliative care teams, as well as clinical and medical oncologists. Patients will undergo MRgHIFU treatment using scanning and treatment planning methods that have been established in the patients treated within the multi-centre study. The treatment response rate for the cohort will be recorded. Intra- and post-procedural imaging metrics will be evaluated for their ability to detect tissue changes, which may be indicative of response. Patients will be followed-up for up to 90 days after treatment, and will attend for repeat imaging and pain review at days 30, 60 and 90 after treatment. Any changes in imaging metrics will be compared between responders and non-responders.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-HIFU of painful bone metastases
- description
- Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases
- interventionNames
- Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
Primary outcomes (1)
- measure
- Measure the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging in responders and non-responders.
- timeFrame
- Day 30
Secondary outcomes (8)
- measure
- To report the treatment response rate.
- timeFrame
- up to 90 days
- description
- Days 7, 14, 30, 60 and 90
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with painful bony metastatic disease * Target bony metastatic lesion is painful (NRS≥4) * Intended target region accessible for MRgHIFU treatment (usually not skull or spinal metastases above the sacrum) * Intended target region visible on non-contrast MR imaging Exclusion Criteria: * MRI contra-indicated (e.g. by incompatible metal implants, claustrophobia, or because BMI precludes accommodation in the MR scanner) * Pregnancy * Sedation contra-indicated * Critical anatomical structure cannot be avoided along the beam path or the at the target (can be assessed at screening) * Internal or external fixation device along the beam path or at the target
References
Publications (0)
Data not yet available