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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05219695
Status
Recruiting
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Conditions

  • Breast Cancer Stage I
  • Fibroadenoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Jan 19, 2022
Status verified
May 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: HMIgFUS
    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.

Primary Outcome Measure

Number of patients with ablation [ Time Frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NYPNew YorkNew York10032
Elisa Konofagou, PhD
[email protected]
212-342-0863
Xiaoyue Li
[email protected]
435-757-9675
Elisa Konofagou, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center/NYP· New York, NY

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