RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-19
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05219695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women age ≥18
  2. * Patients with fibroadenoma (benign tumor) or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes)
  3. * 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)
  1. * Pregnant or lactating women
  2. * Patients with breast implants
  3. * Patients with a history of laser or radiation therapy to the targeted breast
  4. * Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor (other than surgery) as part of clinical care

Contacts and Locations

Study Contact

Elisa Konofagou, PhD
CONTACT
212-342-0863
ek2191@columbia.edu
Xiaoyue J Li, MSc
CONTACT
435-757-9675
xjl2102@columbia.edu

Principal Investigator

Elisa Konofagou, PhD
PRINCIPAL_INVESTIGATOR
Professor of Biomedical Engineering

Study Locations (Sites)

Columbia University Irving Medical Center/NYP
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Elisa Konofagou, PhD, PRINCIPAL_INVESTIGATOR, Professor of Biomedical Engineering

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-19
Study Completion Date2025-05

Study Record Updates

Study Start Date2022-01-19
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Fibroadenoma
  • Breast Cancer Stage I