MR-Guided High-Intensity Focused Ultrasound in Conjunction With Radiation Therapy for the Treatment of Locally Advanced Cervical Cancer

Recruiting in Palo Alto (17 mi)

Overseen byImran Zoberi, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

Stay on Your Current Meds

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

In this study, safety and feasibility of MR-guided HIFU hyperthermia application will be assessed in patients diagnosed with locally advanced cervical cancer. This site has reasonable soft tissue pathways and depths for the ultrasound to access with limited osseous or air interference. Additionally, of cervical cancer patients who develop recurrence following standard treatment, approximately 1/3 will recur locally and an additional 1/3 recur both locally and distantly. Risk of local failure increases with higher FIGO staging. Therefore, patients with locally advanced cervical cancer stand to benefit from adjuvant hyperthermia to potentially increase local disease control outcomes. While MR-HIFU may conceivably increase risk for local complications such as fistula formation, these risks are felt to be acceptable given the potential morbidity of local disease failure, which often can only be addressed curatively by pelvic exenteration. In this study, testing will be performed within tumor volumes involving the cervix uteri. Heating will be to the therapeutic level of 41-42°C for 30-60 minutes, a commonly utilized therapeutic target. This session duration will be achieved in either a single session either before or after the radiotherapy fraction or in an optional two sessions of 15-30 minutes both before and after the radiotherapy fraction, for a total time of 30-60 minutes one day per week. This study will help to elucidate the feasibility of achieving and maintaining therapeutic hyperthermia within an entire tumor volume over the goal period of time of 30-60 minutes. The investigators anticipate that successful completion of this study will lead to further clinical trials investigating the treatment efficacy in terms of added local control compared to traditional, standard-of-care radiotherapy.

Research Team

Imran Zoberi, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

Newly diagnosed histologically or cytologically confirmed locally advanced cervical cancer, FIGO Stage IB2 to IVA

Measurable disease per RECIST 1.1.

At least 18 years of age.

See 4 more

Treatment Details

Interventions

MR-Guided High-Intensity Focused Ultrasound (Other)
Radiation therapy (Radiation)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MR-HIFUExperimental Treatment2 Interventions

-The study team will determine the tumor volume to be treated per standard-of-care diagnostic MRI or CT imaging. An array of scans will be used to align the participant with the HIFU system, optimize heat delivery to the patients, and/or monitor aspects related to the participant such as motion. Vendor-provided software will be used with the participant in each position to create a customized treatment plan for heat delivery. The HIFU device will then be used to apply clinical levels (41-42°C) of heat to the tumor volume. Regions will be heated to the 41-42°C for up to 60 minutes in one session (either before or after radiation) on one day per five to ten standard radiation therapy fractions, with a maximum of 6 days of hyperthermia over the course of their standard, indicated radiation therapy treatment.

Radiation therapy is already approved in Canada, Japan, China, Switzerland for the following indications: