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MRI-Guided Ultrasound Therapy for Head and Neck Cancer (USmBRT-H Trial)

Phase 1
Recruiting
Led By Gregory J Czarnota, PhD, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
All biopsy-confirmed squamous cell carcinoma (SCC) of the H&N including specific subregions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

USmBRT-H Trial Summary

This trial will use MRI-guided ultrasound to increase the effectiveness of radiation therapy delivered by a LINAC machine, in humans.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from staying still during treatment, reactions to contrast agents used in MRIs if applicable, and typical risks associated with radiation therapy such as skin irritation, fatigue, or changes in blood counts.

USmBRT-H Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is a type of skin cancer confirmed by a biopsy.
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My head or neck cancer is between stage I and IV.
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My cancer can be seen on an MRI scan without contrast.
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I understand the study and agree to participate.
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My kidney function, measured by creatinine levels, is normal or nearly normal.
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I am referred for a specific type of radiation therapy or chemoradiation before surgery.
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My cancer can be targeted with a specific type of focused ultrasound.
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I can communicate how I feel during MRg-FU treatment.
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My head or neck cancer cannot be removed with surgery.

USmBRT-H Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of toxicity and adverse events using MRg-FUS MB treatment in patients with head and neck cancer
Secondary outcome measures
Radiological response

USmBRT-H Trial Design

1Treatment groups
Experimental Treatment
Group I: MRg-FUS MB TreatmentExperimental Treatment2 Interventions
Patients with head and neck cancer will receive MRI-guided ultrasound-stimulated microbubble-treatment combined with radiotherapy on a LINAC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DEFINITY
2013
Completed Phase 3
~170

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,422 Total Patients Enrolled
Gregory J Czarnota, PhD, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
6 Previous Clinical Trials
1,990 Total Patients Enrolled

Media Library

MRg-FUS MB Treatment Clinical Trial Eligibility Overview. Trial Name: NCT04431648 — Phase 1
Head and Neck Cancers Research Study Groups: MRg-FUS MB Treatment
Head and Neck Cancers Clinical Trial 2023: MRg-FUS MB Treatment Highlights & Side Effects. Trial Name: NCT04431648 — Phase 1
MRg-FUS MB Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04431648 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what ailment is Definity Suspension for Injection regularly administered?

"Definity Suspension for Injection is a useful tool to assess echocardiography, diseases of the cardiovascular system, and other diagnostic imaging."

Answered by AI

Are there any vacancies within this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this medical experiment is still recruiting participants since it was first posted on May 1st 2020 and last modified on June 22nd 2020. The trial requires 20 volunteers from one location."

Answered by AI

Has Definity Suspension for Injection been given the go-ahead by the FDA?

"Little clinical research has been conducted on Definity Suspension for Injection, so it only earned a rating of 1."

Answered by AI

Could you please provide a synopsis of the investigations which have previously been carried out with Definity Suspension for Injection?

"Presently, 19 trials are taking place for Definity Suspension for Injection; 1 of these is in its final Phase 3. Philadelphia, Pennsylvania is the main hub of activity and there are 26 sites running studies related to this treatment."

Answered by AI

How many participants have signed up for the trial thus far?

"Indeed, the information hosted on clinicaltrials.gov verifies that this research trial is presently seeking participants. The study was first published on May 1st 2020 and most recently updated June 22nd of the same year. It seeks to enroll twenty people from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Head and Neck Cancer
Dr. Gregory Czarnota 2020. "Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04431648.
~0 spots leftby May 2024
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