RecruitingPhase 1NCT05219695

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

Sponsor

Columbia University

Enrollment

82 participants

Start Date

Jan 19, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Stage I Fibroadenoma

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medical imaging technique called harmonic motion imaging (HMI) for guiding high-intensity focused ultrasound (HIFU) — a non-surgical heat treatment — on breast tumors. The goal is to see whether this technology can accurately track the thermal treatment in real time, improving precision and safety. **You may be eligible if...** - You are a woman aged 18 or older - You have a fibroadenoma (a benign, non-cancerous breast lump) or early-stage, non-metastatic breast cancer (stage I, no lymph node involvement) - You are already scheduled for surgical removal of the tumor as part of your regular care **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have breast implants - You have previously received laser or radiation therapy to the same breast - You are scheduled for thermal ablation of the same tumor as part of clinical care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHarmonic motion imaging guided focused ultrasound (HMIgFUS)

Harmonic motion imaging guided focused ultrasound (HMIgFUS) is a combined treatment and imaging method, in which focused ultrasound (FUS) is used to thermally ablate tissue and harmonic motion imaging (HMI) is used for FUS guidance and monitoring. FUS applies high intensity focused ultrasound waves at its specified target to heat the tissue over a specified duration, causing cell death at the target area. HMI is an elasticity imaging technique which induces dynamic tissue vibrations at the target for tissue elasticity characterization. One of the inclusion criteria for this study is that participants must be scheduled for surgical excision of their breast tumor. In this study, HMIgFUS will be applied to anesthetized participants immediately prior to their scheduled surgery. HMI imaging will also be performed immediately prior to and after HMIgFUS application.

PROCEDUREMicrobubble-mediated Low Intensity Focused Ultrasound (LIFU)

Microbubble-mediated Low Intensity Focused Ultrasound (LIFU) is a minimally invasive procedure which delivers localized ultrasound energy to the target region, causing cavitation of microbubbles to safely and transiently increase the permeability of vessels that aids local delivery of medicine.

DRUGMicrobubbles

Definity is a diagnostic ultrasound enhancing agent used to improve the clarity of echocardiograms and other ultrasound images. It consists of tiny, gas-filled lipid microspheres (about the size of a red blood cell) that circulate in the bloodstream to reflect ultrasound waves.