RecruitingNot Applicable

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

United States36 participantsStarted 2022-01-19

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of patients with ablation

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

R2 value of ablated lesion depth

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

R2 value of ablated lesion width

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

R2 value of ablated lesion area

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

Trial details

NCT IDNCT05219695

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Elisa Konofagou, PhD

212-342-0863 ek2191@columbia.edu

View on ClinicalTrials.gov More Fibroadenoma trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of patients with ablation

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

R2 value of ablated lesion depth

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

R2 value of ablated lesion width

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

R2 value of ablated lesion area

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