Using Harmonic Motion Imaging for Non-Invasive Breast Tumor Treatment
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
This study is testing if a new imaging method can help guide a non-invasive ultrasound treatment for people with benign breast tumors and early-stage breast cancer to see if it leads to better recovery and results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05219695 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of Harmonic Motion Imaging (HMI) as a guidance and monitoring tool for Focused Ultrasound Surgery (FUS) in patients with benign breast tumors and stage I breast cancer. The approach focuses on non-invasive treatment, which could lead to faster recovery times and improved cosmetic outcomes compared to traditional surgical methods. By monitoring the mechanical response of the tumor during treatment, the study seeks to enhance the efficacy and safety of FUS. Patients eligible for this study will be those scheduled for surgical resection of their tumors, allowing for a direct comparison of outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with fibroadenoma or early-stage, non-metastatic breast cancer scheduled for surgical resection.
Not a fit: Patients who are pregnant, have breast implants, or have a history of prior thermal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with early-stage breast tumors, reducing recovery time and improving quality of life.
How similar studies have performed: While focused ultrasound has been explored in other contexts, the specific application of HMI for monitoring FUS in breast tumors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center/NYP — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Elisa Konofagou, PhD — Professor of Biomedical Engineering
- Study coordinator: Elisa Konofagou, PhD
- Email: ek2191@columbia.edu
- Phone: 212-342-0863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.