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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Harmonic motion imaging guided focused ultrasound (HMIgFUS)
Procedure/SurgeryHarmonic 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.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: HMIgFUSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with ablation
To identify markers of ablation progression using HMIgFUS images, thereby predicting whether ablation occurred or not. The investigators will also use differences in HMI imaging performed before and after ablation to assess the presence of ablation. The results from both of these methods will be validated with pathological findings, to determine whether ablation was achieved.
Time frame
From the date of ablation and imaging to the date of pathological results (approximately 1 week)2
R2 value of ablated lesion depth
The depth of the lesion (in mm away from the surface of the skin) as shown on HMIgFUS images will be compared and validated with pathological findings.
Time frame
From the date of ablation and imaging to the date of pathological results (approximately 1 week)3
R2 value of ablated lesion width
The width of the lesion (in mm laterally across the lesion) as shown on HMIgFUS images will be compared and validated with pathological findings.
Time frame
From the date of ablation and imaging to the date of pathological results (approximately 1 week)4
R2 value of ablated lesion area
The area of the lesion (in mm\^2) as shown on HMIgFUS images will be compared and validated with pathological findings.
Time frame
From the date of ablation and imaging to the date of pathological results (approximately 1 week)Sponsors and contacts
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Source ClinicalTrials.gov