MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer

NCT06633601 | Recruiting Phase 1 DMC

• 1 other identifier: 5767
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to demonstrate the feasibility 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.

Conditions

Breast Cancer

Keywords

Focused Ultrasound; Breast Cancer; Microbubbles

Outcome Measures

Primary Outcomes (1)

• Safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.

  The primary aim of this research is to evaluate the safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2 years

Secondary Outcomes (1)

• Tumour size response to MRg-FUS + MB and radiation, as measured radiologically or clinically within the treated therapeutic regions.

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All biopsy confirmed breast cancer patients undergoing MRI-Ultrasound Stimulated Microbubble Radiation Treatment plus Radiation Therapy.

Device: MR-Guided Focused Ultrasound Technology; Drug: Definity Suspension for Injection

Interventions

MR-Guided Focused Ultrasound Technology DEVICE

MRI Guidance for use with High-intensity-focused ultrasound (HIFUS)

Also known as: Arrayus System

Treatment Arm

Definity Suspension for Injection DRUG

Microbubble contrast agents for ultrasound

Also known as: Microbubbles

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Terry Fox Research Institute: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections; Microbubbles

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Equipment and Supplies

Study Officials

• Gregory Czarnota, MD, PhD.

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Czarnota, MD, Ph D.

CONTACT

+1 (416) 4806128; GregoyCzarnota@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental Arm

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: October 9, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)