Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05219695

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

Led by Columbia University · Updated on 2025-05-31

36

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center/NYP

New York, New York, United States, 10032

Actively Recruiting

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Research Team

E

Elisa Konofagou, PhD

CONTACT

X

Xiaoyue J Li, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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