Status:
RECRUITING
Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Breast Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Terry Fox Research Institute
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 hum...
Detailed Description
The approach uses relatively low-power ultrasound, operating with lower power levels than high intensity focused ultrasound and ultrasound-based hyperthermia techniques, delivered on the Sonalleve pla...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- All biopsy-confirmed invasive ductal, invasive lobular and other rare histologic types of carcinoma.
- Patients with early stage Breast cancer, or LABC ; i.e., Stage IIA - IIIC cancers (T2 N0 M0 to Any T, N3, M0) or Stage IV (Any T, Any N, M1) per AJCC guidelines (8th Edition).
- Assessed as indicated, by a multidisciplinary team of treating medical, surgical and radiation oncologist and found suitable for radiation treatment.
- Patient referred for standard palliative radiotherapy or curative radiotherapy, which may include (but are not limited to) any of the following dose regimens: 1) 5-8 Gy in one fraction, 2) 20 Gy in 5 fractions, 3) 30 Gy in 5 fractions, 4) 35 Gy in 5 fractions, 5) 30 Gy in 10 fractions, 6) 40 Gy in 10 fractions, 5) 50 Gy in 20 fractions, 6) 60 Gy in 30 fractions and 7) 66 Gy in 33 fractions, or radiobiologically similar doses.
- Able to understand and give informed consent.
- Weight \< 140 kg.
- Target lesion accessible for MRg-FUS+MB procedure.
- Able to communicate sensation during the procedure.
- Creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal.
Exclusion
- Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment.
- Unable to have a contrast-enhanced MRI scan - standard of care criteria.
- Patients having received anthracycline or taxane based chemotherapy within the past 5 days.
- Patients intended for surgical management of the target tumour.
- Patients with metallic or breast implants.
- Subjects with connective tissue disorder, musculoskeletal deformity.
- Target lesion causing deep ulceration, bleeding or discharge of the overlying skin.
- A fibrotic scar along the proposed FUS beam path.
- Severe cardiovascular, neurological, renal or hematological chronic disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 3.
- Any condition that in the investigator's opinion precludes participation.
- Unable to tolerate required stationary position during treatment.
- Allergy to Definity microbubbles.
- Cardiac disease or unstable hemodynamics including myocardial infarction within six months, unstable angina, congestive heart failure, cardiac shunts, cardiac arrhythmia and cardiac pacemaker.
- Contraindication to perflutren including subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation like cisapride, erythromycin, tricyclic antidepressants, Class IA and III antiarrhythmic agents and some antipsychotics like haloperidol, droperidol, quetiapine, thioridazine, ziprasidone.
- Known QT prolongation = (QTc \> 450ms for men or \>470ms for women) with cardiac impairment if ECG is requested as per SOC.
- History of bleeding disorder, coagulopathy.
- Severely impaired renal function with estimated glomerular filtration rate \< 30ml/min/1.73m2 and/or on dialysis.
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06185972
Start Date
July 25 2024
End Date
February 1 2029
Last Update
September 27 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5