This clinical trial assess how harmonic motion imaging guided focused ultrasound surgery or sonoporation can be used in the clinic in treating women with breast tumors. Focused ultrasound surgery is a procedure in which high-energy sound waves are aimed directly at an area of abnormal cells or tissue in the body. The waves create heat that kills the cells. Several imaging techniques are currently being investigated for real-time treatment monitoring of focused ultrasound surgery. Many of these techniques monitor the temperature rise that occurs with thermal ablation. However, some of these methods can be time-consuming, which is not ideal for real-time monitoring; expensive; or prone to errors. Sonoporation uses low-intensity focused ultrasound (LIFU) together with microbubbles to create small, temporary, and reversible effects in tumor blood vessels that may help chemotherapy reach tumor tissue. This trial uses a technique called harmonic motion imaging, which may be better than other imaging techniques in guiding and monitoring breast tumor treatment with focused ultrasound surgery or sonoporation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05219695.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Contact: Bret Taback
Phone: 212-305-9676
PRIMARY OBJECTIVE:
I. To demonstrate the initial clinical feasibility of using harmonic motion imaging (HMI) for guiding and monitoring focused ultrasound surgery (FUS) in patients with benign tumors and stage 1 non-metastatic breast cancers and microbubble-mediated low Intensity focused ultrasound (LIFU), i.e., sonoporation, in early-stage, non-metastatic breast cancer patients.
SECONDARY OBJECTIVE:
I. To investigate the correlation between HMI-informed treatment response with patients’ post-treatment immune profile.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients undergo harmonic motion imaging guided focused ultrasound surgery (HMIgFUS) over 22-42 minutes. Patients undergo blood sample collection on study.
ARM II: Patients undergo ultrasound imaging using HMI then receive standard of care chemotherapy. Within 1 hour of the infusion patients receive perflutren lipid microspheres (Definity) intravenously (IV) over 30 to 60 seconds and undergo sonoporation over 5-10 minutes at part of the tumor site.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorBret Taback
