NCT05219695 Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
| NCT ID | NCT05219695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Fibroadenoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-01-19 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2022-01-19 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Elisa Konofagou, PhD
PRINCIPAL INVESTIGATOR
Professor of Biomedical Engineering
Frequently Asked Questions
Who can join the NCT05219695 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fibroadenoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05219695 currently recruiting?
Yes, NCT05219695 is actively recruiting participants. Contact the research team at ek2191@columbia.edu for enrollment information.
Where is the NCT05219695 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05219695 clinical trial?
NCT05219695 is sponsored by Columbia University. The principal investigator is Elisa Konofagou, PhD at Professor of Biomedical Engineering. The trial plans to enroll 36 participants.