MRI-Guided Ultrasound Therapy for Head and Neck Cancer

(USmBRT-H Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Gregory J Czarnota, PhD, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

Research Team

Gregory J Czarnota, PhD, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

Adults over 18 with certain types of head and neck cancer (squamous cell carcinoma) that can't be removed by surgery or are inoperable. They should have a lesion visible on MRI, weigh less than 140kg, and not have had recent surgeries or other treatments. Participants must also be able to undergo standard radiotherapy and tolerate the treatment position.

Inclusion Criteria

I am 18 years old or older.

My cancer is a type of skin cancer confirmed by a biopsy.

My head or neck cancer is between stage I and IV.

Exclusion Criteria

I had surgery on my head or neck, not including biopsy, less than 6 weeks ago.

Pregnant or lactating women

I have a scar or implant where the treatment beam will go.

Treatment Details

Interventions

• DEFINITY PERFLUTREN INJECTABLE SUSPENSION (Radiosensitizer)
• Definity Suspension for Injection (Radiosensitizer)

Trial Overview The trial is testing a new method using MRI-guided ultrasound with microbubbles to enhance radiation therapy's effectiveness for treating head and neck cancers. Patients will receive this experimental treatment alongside their regular external beam radiotherapy.

Participant Groups

Group I: MRg-FUS MB Treatment Experimental Treatment 2 Interventions

Patients with head and neck cancer will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Dr. Rajin Mehta

Sunnybrook Health Sciences Centre

Chief Medical Officer

MD from University of Toronto

Dr. Andrew J. Smith

Sunnybrook Health Sciences Centre

President and CEO since 2017

MD, MSc from University of Toronto; Surgical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center