Using Harmonic Motion Imaging for Non-Invasive Breast Tumor Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Focused Ultrasound Surgery

Inclusion criteria:

* Women age 18 years or older with benign tumors 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 their clinical care team

Exclusion criteria:

* Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor as part of their clinical care
* Pregnant or lactating
* Presence of breast implants
* Have a history of laser or radiation therapy to the targeted breast.

Microbubble-mediated LIFU, i.e., sonoporation

Inclusion criteria:

* Women 18 years or older
* Deemed eligible to receive neoadjuvant systemic therapy as per the treating physician, with the dose and schedule deemed appropriate by the treating physician
* Any stage invasive breast cancer provided the primary breast tumor size is at least 4 mm

Exclusion criteria:

* Pregnant or lactating
* Presence of breast implants
* History of laser or radiation therapy to the affected breast
* Contraindication history or hypersensitivity to ultrasound contrast agents, e.g., Definity, including polyethylene glycol (PEG) allergy.

Where it's running

• Columbia University Irving Medical Center/NYP
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Bret Taback, MD — Columbia University
• Study coordinator: Shiqi Hu, MSc
• Email: sh4193@columbia.edu
• Phone: 917-664-5382

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.