Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients With Chest-wall and Locally-Advanced Breast Cancer

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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 radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• All biopsy-confirmed invasive ductal, invasive lobular and other rare histologic types of carcinoma within past three months

• Patients with early stage Breast cancer, or LABC ; i.e., Stage IIA - IIIC cancers (T2 N0 M0 to Any T, N3, M0) 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 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

• Patient with normal coagulation profile, CBC, liver profile (bilirubin/ ALT/ALP), electrolytes (sodium, potassium, chloride, CO2 total), BUN and creatinine.

Exclusion Criteria:

• 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)

• Patients concurrently taking anti-coagulant therapy like antiplatelets or vitamin K inhibitors or heparin derivatives

• History of bleeding disorder, coagulopathy

• Severely impaired renal function with estimated glomerular filtration rate < 30ml/min/1.73m2 and/or on dialysis