NCT03007771

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

• Healthy Participants
• Pelvic Neoplasms
• Soft-tissue Sarcoma
• Bladder Cancer
• Cervical Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DEVICE	Magnetic Resonance-guided High-Intensity Focused Ultrasound	-Heating will not be performed in two areas of the body near each other (for example, not heating in two different places of the same thigh) to minimize the risk of overheating any one part of the subject's body. Heating a second target site is not mandatory, even if time allows, and the participant may refuse.

Timeline

• Start date: 2017-09-30
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2017-01-02
• Last updated: 2017-10-06

Regulatory

• FDA-regulated device study