About this trial
This study will investigate Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) method for ablation and sonoporation monitoring of breast tumors. The aim of this study is to evaluate the efficacy of real-time guidance/monitoring and ablation/sonoporation method. The hypothesis behind this proposed study is that High Intensity Focused Ultrasound (HIFU) can be used to ablate tumor tissue, and microbubble-mediated Low Intensity Focused Ultrasound (LIFU) can be used to sonoporate tumor vasculature. The investigators of this study also hypothesize that HMI can be used to monitor HIFU ablation by measuring the changes in tissue stiffness that occur as a result of thermal ablation, guide LIFU sonoporation and HIFU ablation targeting stiff tumor tissue, and the HMI-monitored stiffness changes during ablation will correlate with post-treatment immune response. The ultimate goals of this study are: first, to assess whether these techniques can be used in the clinic in order to provide a well-monitored, noninvasive tumor ablation/sonoporation method for benign tumors and breast cancers, to minimize side effects due to invasiveness and enhance therapeutic effects of current methods; second, to make full use of the real-time monitoring capability of HMIgFUS for more precise, point-of-care treatment planning to ensure success of ablation/sonoporation and immune activation.
Eligibility criteria
Qualifiers
Women age 18 years or older with benign tumors or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes)
Scheduled to receive surgical resection of the tumor by their clinical care team
Disqualifiers
Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor as part of their clinical care
Pregnant or lactating
Presence of breast implants
Have a history of laser or radiation therapy to the targeted breast.
Trial design
Treatments tested in this trial
- Harmonic motion imaging guided focused ultrasound (HMIgFUS)
- Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)
- Microbubbles
Treatment groups
Sponsors and collaborators
Columbia University
Lead sponsor
National Cancer Institute (NCI)
Collaborator