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Virus Therapy

Ultrasound-Enhanced Radiation Therapy for Breast Cancer

Phase 1

Recruiting

Led By Gregory Czarnota, MD, PhD.

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

Creatinine within normal institutional limits or creatinine clearance > 60mL/min/1.73m2

Patients with early stage Breast cancer or LABC (Stage IIA - IIIC cancers or Stage IV per AJCC guidelines)

Must not have

Received anthracycline or taxane based chemotherapy within the past 5 days

Connective tissue disorder or musculoskeletal deformity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new method that uses MRI-guided ultrasound to improve the effects of radiation therapy in cancer patients.

Who is the study for?

This trial is for individuals with chest-wall or locally advanced breast cancer. Specific eligibility details are not provided, but typically participants must meet certain health criteria and have a type of cancer that the study targets.

What is being tested?

The study tests if MRI-guided ultrasound stimulated microbubbles can boost the effectiveness of radiation therapy in treating breast cancer. Participants will receive this novel treatment alongside standard external beam radiotherapy from a LINAC device.

What are the potential side effects?

Potential side effects are not detailed, but may include discomfort from the MRI procedure or reactions to the Definity injection like headache, nausea, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal or nearly normal.

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My breast cancer is at an early or locally advanced stage (IIA-IIIC) or stage IV.

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I understand the study and agree to participate.

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I am 18 years old or older.

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I am referred for radiotherapy as part of my treatment plan.

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My breast cancer is confirmed by biopsy and is not the common type.

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My cancer can be targeted with a specific ultrasound procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had anthracycline or taxane chemotherapy in the last 5 days.

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I have a connective tissue disorder or a deformity in my bones or muscles.

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My cancer has caused deep sores or bleeding on my skin.

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I have a history of bleeding disorders.

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My kidney function is very low or I am on dialysis.

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I need help with my daily activities due to my health condition.

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I cannot take perflutren due to health reasons.

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I have a heart condition related to long QT syndrome.

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I have a scar tissue in the area where they plan to use focused ultrasound.

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I do not have severe heart, brain, kidney, or blood disease.

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I cannot stay still for long periods during treatment.

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I have not had heart disease or unstable blood pressure in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.

Secondary study objectives

Tumour size response to MRg-FUS + MB and radiation, as measured radiologically or clinically within the treated therapeutic regions.

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: Treatment ArmExperimental Treatment2 Interventions

All biopsy confirmed breast cancer patients undergoing MRI-Ultrasound Stimulated Microbubble Radiation Treatment plus Radiation Therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Definity Suspension for Injection

2014

Completed Phase 1

~50

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Terry Fox Research InstituteOTHER

10 Previous Clinical Trials

1,538 Total Patients Enrolled

2 Trials studying Breast Cancer

700 Patients Enrolled for Breast Cancer

Sunnybrook Health Sciences CentreLead Sponsor

673 Previous Clinical Trials

1,565,837 Total Patients Enrolled

30 Trials studying Breast Cancer

17,052 Patients Enrolled for Breast Cancer

Gregory Czarnota, MD, PhD.Principal InvestigatorSunnybrook Health Sciences Centre

~20 spots leftby Mar 2026

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