MRI-guided ultrasound treatment for advanced breast cancer
A Prospective, Single-Centre, Single-Arm, Non-Randomized, Phase-I, MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer - a Pilot Study
This study is testing if using MRI-guided ultrasound with tiny bubbles can make radiation therapy work better for people with advanced breast cancer who can't have surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06633601 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility of using MRI-guided ultrasound-stimulated microbubbles to enhance the effects of radiation therapy in patients with locally advanced breast cancer and chest wall tumors. Participants will receive focused ultrasound treatment followed by standard LINAC-based radiation therapy. The study is a single-centre, single-arm, non-randomized Phase I trial, focusing on patients who are not candidates for surgical intervention. The goal is to improve treatment outcomes for patients with challenging breast cancer cases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-confirmed invasive breast cancer, particularly those with locally advanced or unresectable tumors.
Not a fit: Patients with early-stage breast cancer or those who are not suitable for radiation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the effectiveness of radiation therapy for patients with advanced breast cancer.
How similar studies have performed: While this approach is innovative, similar studies using focused ultrasound in cancer treatment have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 \>60mL/min/ Novel MRI-Guided Ultrasound Stimulated Microbubble Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer. 1.73m2 for patients with creatinine levels above institutional upper limit of normal. Exclusion Criteria: * 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 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.
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gregory Czarnota, MD, PhD. — Sunnybrook Health Sciences Centre
- Study coordinator: Gregory Czarnota, MD, Ph D.
- Email: GregoyCzarnota@sunnybrook.ca
- Phone: +1 (416) 4806128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.