Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia

The Washington University

Status and phase: Withdrawn; Phase 1

Conditions: Bladder Cancer; Healthy Participants; Soft-tissue Sarcoma; Pelvic Neoplasms; Cervical Cancer; Rectal Cancer

Treatments: Device: Magnetic Resonance-guided High-Intensity Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03007771

201612155

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

MR-HIFU

Experimental group

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.

Treatment:

Device: Magnetic Resonance-guided High-Intensity Focused Ultrasound