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

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.