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

Cervical Cancer Clinical Trial

Official title:

A Feasibility Study of Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia in Human Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03007771
• Other study ID #: 201612155
• Status: Withdrawn
• Phase: Phase 1
• First received: December 29, 2016
• Last updated: October 4, 2017
• Start date: September 30, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	-Temperature in the participant will be monitored using MR thermometry with the MR scanner	1 day (2 hour timeframe)
Primary	Feasibility of the MR-HIFU device as measured by whether an area can be heated while simultaneously maintaining patient comfort	Patient comfort will be measured by the Comfort Score. Before 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. After the scan, the same questions will be asked again of the subject.; Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness). Participants will be asked to score pain/discomfort on a scale of 1-10, with 1 being minimal/none and 10 being extreme.	Up to 10 days
Primary	Feasibility of the MR-HIFU device as measured by whether coupling can be maintained with the body area in the same position while having contact with the transducer for an appropriate time frame.	-Patients' skin will be cooled using the MR-HIFU system's direct skin cooling device to minimize over heating of the skin, unless one or more gel pads are required to achieve proper coupling to the HIFU system. In order to ensure good contact with the surface of the HIFU interface, participants may be shaved or have other hair-removal products applied to limited regions of their body.	1 day (2 hour timeframe)
Secondary	Behavior of hyperthermia delivery as measured by the build-up of time until the different treatment cells can reach a desired uniform temperature	--Temperature in the participant will be monitored using MR thermometry with the MR scanner	1 day (2 hour time frame)
Secondary	Behavior of hyperthermia delivery as measured by if the heating cell behavior is the same in healthy and tumor tissues	--Temperature in the participant will be monitored using MR thermometry with the MR scanner	1 day (2 hour time frame)
Secondary	Behavior of hyperthermia delivery as measured by post-treatment heat diffusion behavior to anticipate any issues when heat is given at a clinically relevant level	-Participants will be contacted by phone 5-10 days following participation in the study. Participants will be asked to describe any negative effects in the area heated since participation in the study, including pain, discomfort, and/or cosmetic changes (such as skin redness).	Up to 10 days

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine