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

NCT05219695 | Recruiting

• 1 other identifier: AAAS9859
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroadenoma; Breast Cancer Stage I

Outcome Measures

Primary Outcomes (4)

• Number of patients with ablation

  To identify markers of ablation progression using HMIgFUS images, thereby predicting whether ablation occurred or not. The investigators will also use differences in HMI imaging performed before and after ablation to assess the presence of ablation. The results from both of these methods will be validated with pathological findings, to determine whether ablation was achieved.

  From the date of ablation and imaging to the date of pathological results (approximately 1 week)

• R2 value of ablated lesion depth

  The depth of the lesion (in mm away from the surface of the skin) as shown on HMIgFUS images will be compared and validated with pathological findings.

  From the date of ablation and imaging to the date of pathological results (approximately 1 week)

• R2 value of ablated lesion width

  The width of the lesion (in mm laterally across the lesion) as shown on HMIgFUS images will be compared and validated with pathological findings.

  From the date of ablation and imaging to the date of pathological results (approximately 1 week)

• R2 value of ablated lesion area

  The area of the lesion (in mm\^2) as shown on HMIgFUS images will be compared and validated with pathological findings.

  From the date of ablation and imaging to the date of pathological results (approximately 1 week)

Study Arms (1)

HMIgFUS

EXPERIMENTAL

Each study participants' tumors will be imaged using Harmonic Motion Imaging (HMI), an ultrasound elastography method. A central portion of the tumor will then be ablated and monitored using Harmonic Motion Imaging guided Focus Ultrasound (HMIgFUS). Only one portion of the tumor will be ablated; the other portions of the tumor, including tumor margins, will not be ablated. Following ablation, the tumor will be imaged again using HMI.

Procedure: Harmonic motion imaging guided focused ultrasound (HMIgFUS)

Interventions

Harmonic motion imaging guided focused ultrasound (HMIgFUS) PROCEDURE

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.

HMIgFUS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center/NYP

New York, New York, 10032, United States

RECRUITING

Related Publications (2)

• Han Y, Wang S, Payen T, Konofagou E. Fast lesion mapping during HIFU treatment using harmonic motion imaging guided focused ultrasound (HMIgFUS) in vitro and in vivo. Phys Med Biol. 2017 Apr 21;62(8):3111-3123. doi: 10.1088/1361-6560/aa6024. Epub 2017 Mar 21.

  PMID: 28323638 BACKGROUND

• Han Y, Wang S, Hibshoosh H, Taback B, Konofagou E. Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). Breast Cancer Res. 2016 May 9;18(1):46. doi: 10.1186/s13058-016-0707-3.

  PMID: 27160778 BACKGROUND

MeSH Terms

Conditions

Fibroadenoma; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisa Konofagou, PhD

  Professor of Biomedical Engineering

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Konofagou, PhD

CONTACT

212-342-0863; ek2191@columbia.edu

Xiaoyue J Li, MSc

CONTACT

435-757-9675; xjl2102@columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomedical Engineering

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: January 19, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)