Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
Healthy Participants, Pelvic Neoplasms, Soft-tissue Sarcoma
About this trial
This is an interventional device feasibility trial for Healthy Participants
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
MR-HIFU
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.