Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University

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

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Columbia University

Lead sponsor

National Cancer Institute (NCI)

Collaborator