Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Harmonic motion imaging guided focused ultrasound (HMIgFUS)
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov