Actively Recruiting
MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer
Led by Sunnybrook Health Sciences Centre · Updated on 2024-10-09
30
Participants Needed
1
Research Sites
243 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 feasibility 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
MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E= 18 years.
- Biopsy-confirmed invasive ductal, invasive lobular, or other rare histologic types of carcinoma.
- Diagnosis of early stage Breast cancer or locally advanced breast cancer (Stage IIA to IIIC) or Stage IV per AJCC guidelines (8th Edition).
- Assessed by a multidisciplinary team and found suitable for radiation treatment.
- 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 MRg-FUS plus microbubble procedure.
- Able to communicate sensation during the procedure.
- Creatinine within normal institutional limits or creatinine clearance greater than 60 mL/min or 1.73 m2 for patients with elevated creatinine levels.
You will not qualify if you...
- Pregnant or lactating women.
- Unable to have a contrast-enhanced MRI scan.
- Received anthracycline or taxane based chemotherapy within the past 5 days.
- Presence of metallic or breast implants.
- Connective tissue disorder or musculoskeletal deformity.
- Target lesion causing deep ulceration, bleeding, or skin discharge.
- Fibrotic scar along the proposed focused ultrasound beam path.
- Severe cardiovascular, neurological, renal, or hematological chronic disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 3 or higher.
- Any condition that precludes participation per investigator judgment.
- Unable to tolerate required stationary position during treatment.
- Allergy to Definity microbubbles.
- Cardiac disease or unstable hemodynamics including recent myocardial infarction, unstable angina, congestive heart failure, cardiac shunts, arrhythmia, or pacemaker.
- Contraindication to perflutren including history of QT prolongation or use of medications that prolong QT interval.
- Known QT prolongation with cardiac impairment if ECG is required.
- History of bleeding disorder or coagulopathy.
- Severely impaired renal function with estimated glomerular filtration rate less than 30 ml/min/1.73 m2 or dialysis.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
G
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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