Recruiting
Phase 2

Microbubble Radiation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06185972

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Definity

Sonalleve Focused Ultrasound Device

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06185972

Start date

Jul 25, 2024

Status verified date

Dec, 2023

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Treatment Arm

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

Interventions

Definity

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Sonalleve Focused Ultrasound Device

Sonalleve Focused Ultrasound Device

Primary outcome measure

  • Primary Outcomes/Endpoint [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Dr.Gregory Czarnota, MD, Ph.D.

+1 (416) 480-6128Gregory.Czarnota@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Dr. Gregory Czarnota, PhD, MD

(416) 480-6128gerogory.czarnota@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Sep 27, 2024

Last verified

Dec, 2023

Keywords

  • Focused Ultrasound
  • Breast Cancer
  • Microbubbles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-09-27.