Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Breast Cancer

NCT ID: NCT06185972

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2029-02-01

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 humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

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 platform. The tumour will be sonicated before the radiation to enhance the effect of therapy. The technique is spatially targeted and stimulates microbubbles using low-power ultrasonic fields in the tumour location only. The primary aim is to evaluate tumour response to MRg-FUS + MB and radiation, as measured radiologically or clinically within the treated therapeutic target regions.The secondary aim of this research is to evaluate early and late effect profiles of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year after treatment.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Treatment Arm

All biopsy confirmed breast cancer patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy

Group Type: EXPERIMENTAL

Definity

Intervention Type: DRUG

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Sonalleve Focused Ultrasound Device

Intervention Type: DEVICE

Sonalleve Focused Ultrasound Device

Interventions

Definity

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Intervention Type: DRUG

Sonalleve Focused Ultrasound Device

Sonalleve Focused Ultrasound Device

Intervention Type: DEVICE

Other Intervention Names

Microbubbles

Eligibility 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 >60 mL/min/1.73 m2 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terry Fox Research Institute

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Gregory Czarnota, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Dr.Gregory Czarnota, MD, Ph.D.

Role: CONTACT

Gregory.Czarnota@sunnybrook.ca

+1 (416) 480-6128 ext. 7073

Facility Contacts

Dr. Gregory Czarnota, PhD, MD

Role: primary

gerogory.czarnota@sunnybrook.ca

(416) 480-6128

Other Identifiers

5768

Identifier Type: -

Identifier Source: org_study_id