Actively Recruiting
Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Breast Cancer
Led by Sunnybrook Health Sciences Centre · Updated on 2024-09-27
200
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
T
Terry Fox Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this study is to demonstrate the efficacy and response of novel Magnetic Resonance Imaging (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.
CONDITIONS
Official Title
Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Biopsy-confirmed invasive ductal, invasive lobular, or other rare types of breast carcinoma
- Early stage or locally advanced breast cancer (Stage IIA to IIIC) or Stage IV per AJCC 8th Edition
- Suitable for radiation therapy as assessed by a multidisciplinary oncology team
- Referred for standard palliative or curative radiotherapy with specified dose regimens
- Able to understand and provide informed consent
- Weight less than 140 kg
- Target lesion accessible for MRI-guided focused ultrasound and microbubble procedure
- Able to communicate sensations during treatment
- Normal kidney function or creatinine clearance above 60 mL/min/1.73 m2 if creatinine is elevated
You will not qualify if you...
- Pregnant or breastfeeding women
- Unable to undergo contrast-enhanced MRI scan
- Received anthracycline or taxane chemotherapy within 5 days prior
- Planned surgical management of the target tumor
- Presence of metallic or breast implants
- Connective tissue disorders or musculoskeletal deformities
- Target lesion with deep ulceration, bleeding, or skin discharge
- Fibrotic scar along the ultrasound beam path
- Severe chronic cardiovascular, neurological, renal, or blood diseases
- ECOG performance status 3 or higher
- Any condition that prevents participation as judged by the investigator
- Unable to remain still during treatment
- Allergy to Definity microbubbles
- Cardiac disease or unstable heart conditions including recent myocardial infarction, unstable angina, heart failure, arrhythmia, or pacemaker
- Contraindications to perflutren or history of QT prolongation or use of medications causing QTc prolongation
- Known QT prolongation with cardiac impairment if ECG is required
- History of bleeding disorders or coagulopathy
- Severely impaired kidney function with GFR below 30 mL/min/1.73 m2 or dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
D
Dr.Gregory Czarnota, MD, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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