Clinical trial · Interventional
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
A Feasibility Study of Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia in Human Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decision was made to not go forward with the study
Summary
Brief summary (as posted)
This study will help to elucidate the treatment sites in the extremities and pelvis for which MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The investigators anticipate that successful completion of this study will lead to clinical trials in those feasible sites of interest to determine the safety and efficacy of administering therapeutic levels of heat for hyperthermia or other applications.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Healthy Participants | — | UNRESOLVED | — |
| Pelvic Neoplasms | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Soft-tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance-guided High-Intensity Focused Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-HIFU
- description
- * Philips 1.5T MRI scanner equipped with a Sonalleve V2 HIFU system will be used * Will be scanned in the MRI in 1 or more positions to the extremities and/or pelvis while aligned to the HIFU system. The HIFU device will then be used to apply sub-clinical levels (≤ 41°C) of heat to one or more small volumes. Regions will be heated to the desired temperature for variable short durations of time not exceeding 30 minutes. * After the session is complete, the patient will be removed from the MR-HIFU system and, following a 15-30-minute period of monitoring for any adverse events, allowed to leave. * Before the scan, after the scan and 5-10 days following the scan, participants will be asked to rate any pain, discomfort, in the area to be heated, as well as any anxiety or claustrophobia on a scale of 1-10 with 1 being minimal/none and 10 being extreme. The skin area to be treated will also be reviewed for any redness/discoloration.
- interventionNames
- Device: Magnetic Resonance-guided High-Intensity Focused Ultrasound
Primary outcomes (3)
- measure
- Feasibility of the MR-HIFU device as measured by whether an area can be heated to the designated temperature and held at that temperature for an appropriate time frame
- timeFrame
- 1 day (2 hour timeframe)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age * Willing and able to provide informed consent * Patients only: must have a tumor in extremity muscle tissue or in the pelvis. Exclusion Criteria: * Contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia) * Pregnant
References
Publications (0)
Data not yet available