RecruitingNot ApplicableNCT05219695

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

Sponsor

Columbia University

Enrollment

36 participants

Start Date

Jan 19, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Stage I Fibroadenoma

Summary

The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

Women age ≥18
Patients with fibroadenoma (benign tumor) 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 the clinical care team (ideal target lesion upper boundary should be deeper than 1 cm below the skin, and the ideal size of the lesion should be 2-5 cm in diameter)

Exclusion Criteria4

Pregnant or lactating women
Patients with breast implants
Patients with a history of laser or radiation therapy to the targeted breast
Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor (other than surgery) as part of clinical care

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.