Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Columbia University
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.
Description
Patients with small solid tumors without positive lymph nodes have the highest survival rate. However, especially for patients with benign tumors (most common in younger women) and older patients (\>65 years old) who fit these criteria, an alternative treatment technique that is less invasive than the current surgical or invasive ablative intervention may be more beneficial. FUS is a noninvasive, non-ionizing treatment procedure that precisely focuses and delivers a large amount of ultrasound energy to the target area, causing localized temperature rise and cell necrosis at the target. The mai…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 o…
Interventions
- ProcedureHarmonic motion imaging guided focused ultrasound (HMIgFUS)
Harmonic motion imaging guided focused ultrasound (HMIgFUS) is a combined treatment and imaging method, in which focused ultrasound (FUS) is used to thermally ablate tissue and harmonic motion imaging (HMI) is used for FUS guidance and monitoring. FUS applies high intensity focused ultrasound waves at its specified target to heat the tissue over a specified duration, causing cell death at the target area. HMI is an elasticity imaging technique which induces dynamic tissue vibrations at the target for tissue elasticity characterization. One of the inclusion criteria for this study is that participants must be scheduled for surgical excision of their breast tumor. In this study, HMIgFUS will be applied to anesthetized participants immediately prior to their scheduled surgery. HMI imaging will also be performed immediately prior to and after HMIgFUS application.
Location
- Columbia University Irving Medical Center/NYPNew York, New York