Fast lesion mapping during HIFU treatment using harmonic motion imaging guided focused ultrasound (HMIgFUS) in vitro and in vivo.
Yang Han, Shutao Wang, Thomas Payen...
https://pubmed.ncbi.nlm.nih.gov/28323638Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID05219695
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Harmonic Motion Imaging (HMI) combined with Focused Ultrasound Surgery (FUS) to guide and monitor treatment in patients with benign and early-stage non-metastatic breast cancers. This study aims to demonstrate the clinical feasibility of this noninvasive approach and assess whether changes in HMI measurements can indicate how well the FUS ablation is progressing. The goal is to offer an alternative to surgical or invasive treatments, especially for patients with small tumors and those who may benefit from less invasive procedures. Participants will undergo imaging of their breast tumors using HMI, which measures tissue stiffness through ultrasound elasticity techniques. Then, a central portion of the tumor will be ablated using focused ultrasound guided by HMI (called HMIgFUS). Only part of the tumor will be treated, while the rest remains intact. After ablation, the tumor will be imaged again with HMI. Following this procedure, patients will proceed with their planned surgical tumor removal as part of their regular care. During the study, participants will be monitored through imaging before and after the ablation procedure. Researchers will measure factors such as the depth, width, and area of the ablated lesion and compare these to pathological results obtained about one week later. This study focuses on safety and imaging accuracy in a low-risk setting, as the tumor will be surgically removed after the study procedure. The total duration from ablation and imaging to pathology results is approximately one week.
CONDITIONS
Brief Title
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Women age 18 years or older
- Diagnosis of fibroadenoma (benign tumor) or early-stage, non-metastatic breast cancer (stage I without lymph node involvement)
- Scheduled for surgical removal of the breast tumor
- Tumor size ideally between 2 and 5 cm in diameter
- Tumor upper boundary ideally more than 1 cm below the skin surface
You will not qualify if you...
- Pregnant or lactating women
- Presence of breast implants
- History of laser or radiation therapy to the targeted breast
- Prior or planned 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Single day prior to surgery
Participants undergo Harmonic Motion Imaging (HMI) to image the tumor, followed by a focused ultrasound ablation of a central portion of the tumor guided and monitored by HMI. Imaging is repeated after ablation. This occurs immediately prior to the participant's scheduled surgical tumor removal.
1 treatment visit (in-person)
Surgery
Duration - 1 day
Participants undergo surgical removal of the breast tumor following the HMI guided focused ultrasound treatment.
1 surgery visit (in-person)
Follow-up
Duration - Approximately 1 week
Participants are monitored until pathological results are available approximately 1 week after ablation and surgery.
1 follow-up visit (in-person)
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
X
Xiaoyue J Li, MSc
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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Published Research Related To This Trial
Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI).
Yang Han, Shutao Wang, Hanina Hibshoosh...
https://pubmed.ncbi.nlm.nih.gov/27160778