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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
Must not have
Head and neck surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment
Fibrotic scar or orthopedic implant along proposed FU beam path
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had surgery on my head or neck, not including biopsy, less than 6 weeks ago.
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I have a scar or implant where the treatment beam will go.
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I cannot take perflutren due to health reasons.
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I have very high blood pressure.
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My kidneys do not work well.
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I do not have severe heart, brain, kidney, or blood diseases.
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I need help with my daily activities due to my health condition.
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I have a history of bleeding disorders.
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I have heart problems or unstable blood pressure.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
681 Previous Clinical Trials
1,565,738 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
~4 spots leftby Dec 2025
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