Status:
RECRUITING
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Lead Sponsor:
Columbia University
Conditions:
Fibroadenoma
Breast Cancer Stage I
Eligibility:
FEMALE
18+ years
Phase:
NA
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 beni...
Detailed Description
Patients with small solid tumors without positive lymph nodes have the highest survival rate. However, especially for patients with benign tumors (most common in younger women) and older patients (\>6...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05219695
Start Date
January 19 2022
End Date
May 1 2026
Last Update
May 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center/NYP
New York, New York, United States, 10032