Status:
COMPLETED
Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Chest-wall and Breast Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherap...
Detailed Description
The objective of this study is to demonstrate the feasibility of novel MRI-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherap...
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 by a multidisciplinary team of treating medical, surgical and radiation oncologist and found suitable for the treatment
- Patient referred for palliative radiotherapy or standard radiotherapy, which may include any of the following dose regimens: 1) 20 Gy in 5 fractions, 2) 30 Gy in 10 fractions, 3) 40 Gy in 10 fractions, 4) 50 Gy in 20 fractions, 5) 60 Gy in 30 fractions and 6) 66 Gy in 33 fractions.
- Able to understand and give informed consent
- Weight \< 140 kg
- Target lesion accessible for MRg-FU+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. Women/ men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Unable to have a contrast-enhanced MRI scan - standard of care criteria
- Patients on anthracycline or taxane based chemotherapy
- Patients with metallic or breast implants
- Subjects with inflammatory breast cancer, connective tissue disorder, musculoskeletal deformity
- Target lesion causing ulceration, bleeding or discharge of the overlying skin
- A fibrotic scar along the proposed FU beam path
- Severe cardiovascular, neurological, renal or hematological chronic disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 3
- Any condition in the investigator's opinion precludes participation
- Bleeding disorders/ High risk for deep vein thrombosis
- Unable to tolerate required stationary position during treatment
- Allergic to Definity microbubbles
- Cardiac disease or unstable hemodynamics including myocardial infarction within six months, unstable angina, congestive heart failure, ejection fraction \< 50%, cardiac shunts, cardiac arrythmia 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.
- QT prolongation observed on screening ECG (QTc \> 450ms for men or \>470ms for women)
- Severe hypertension (diastolic BP \> 100 mmHg)
- 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 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04431674
Start Date
July 22 2020
End Date
June 21 2023
Last Update
December 13 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5