Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Launched by COLUMBIA UNIVERSITY · Jan 21, 2022
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new imaging technique called Harmonic Motion Imaging (HMI) to help guide and monitor a type of treatment called Focused Ultrasound Surgery (FUS) for women with breast tumors. The study aims to see if HMI can provide useful information about how the treatment is working for patients with benign tumors, like fibroadenomas, or early-stage breast cancer that has not spread to other parts of the body.
To participate in the trial, women must be at least 18 years old and have either a fibroadenoma or stage I breast cancer. They should be planning to have surgery to remove their tumor, which should be located deeper than 1 cm below the skin and between 2-5 cm in size. However, pregnant women, those with breast implants, or anyone who has had previous treatment on the targeted breast area cannot join. Participants will undergo imaging and treatment, and the study will help researchers understand how effective this new method is in monitoring tumor treatment.
Gender
FEMALE
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
About Columbia University
Columbia University, a prestigious Ivy League institution located in New York City, is a leading sponsor of clinical trials dedicated to advancing medical research and improving patient care. With a robust network of research facilities and a commitment to innovation, Columbia University collaborates with a diverse range of healthcare professionals and researchers to explore groundbreaking therapies and treatment methodologies. The university's clinical trials encompass various fields, including oncology, neurology, and public health, aiming to translate scientific discoveries into effective clinical applications. Columbia University is dedicated to maintaining the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants while contributing to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Elisa Konofagou, PhD
Principal Investigator
Professor of Biomedical Engineering
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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