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RECRUITING
NCT05219695
NA

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

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2022-01-19

Completion Date

2026-05

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

PROCEDURE

Harmonic 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.

Locations (1)

Columbia University Irving Medical Center/NYP

New York, New York, United States