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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    20
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 4 October 2022
carcinoma
advanced breast cancer
breast cancer staging

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.

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 radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device. The investigators have previously demonstrated that ultrasound and microbubble mediated endothelial cell perturbation can significantly enhance the effectiveness of radiation. It enhances tumour response to radiation significantly by synergistically destroying tumour blood vessels. The technique is targeted spatially and achieves tumour specificity by confining the low-power ultrasonic fields that stimulate microbubbles to the tumour location only. By perturbing the tumour vasculature and activating specific genetic pathways, the technique sensitizes the targeted tissues to the subsequent therapeutic application of radiation, resulting in significantly enhanced cell killing. The primary aim of this research is to evaluate the safety profile of MRI-guided ultrasound stimulated microbubble treatment and radiation in patients with chest wall and breast cancer. The secondary aim is to evaluate tumor (primary and/or nodal) response to MRg-FU + MB and radiation, as measured radiologically within the treated therapeutic regions.

Details
Condition Breast Cancer
Treatment Definity Suspension for Injection
Clinical Study IdentifierNCT04431674
SponsorSunnybrook Health Sciences Centre
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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) 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 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
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