Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University
About this trial
This study will investigate Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) method for ablation and sonoporation monitoring of breast tumors. The aim of this study is to evaluate the efficacy of real-time guidance/monitoring and ablation/sonoporation method. The hypothesis behind this proposed study is that High Intensity Focused Ultrasound (HIFU) can be used to ablate tumor tissue, and microbubble-mediated Low Intensity Focused Ultrasound (LIFU) can be used to sonoporate tumor vasculature. The investigators of this study also hypothesize that HMI can be used to monitor HIFU ablation by measuring the changes in tissue stiffness that occur as a result of thermal ablation, guide LIFU sonoporation and HIFU ablation targeting stiff tumor tissue, and the HMI-monitored stiffness changes during ablation will correlate with post-treatment immune response. The ultimate goals of this study are: first, to assess whether these techniques can be used in the clinic in order to provide a well-monitored, noninvasive tumor ablation/sonoporation method for benign tumors and breast cancers, to minimize side effects due to invasiveness and enhance therapeutic effects of current methods; second, to make full use of the real-time monitoring capability of HMIgFUS for more precise, point-of-care treatment planning to ensure success of ablation/sonoporation and immune activation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
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.
Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)
Procedure/SurgeryMicrobubble-mediated Low Intensity Focused Ultrasound (LIFU) is a minimally invasive procedure which delivers localized ultrasound energy to the target region, causing cavitation of microbubbles to safely and transiently increase the permeability of vessels that aids local delivery of medicine.
Microbubbles
DrugDefinity is a diagnostic ultrasound enhancing agent used to improve the clarity of echocardiograms and other ultrasound images. It consists of tiny, gas-filled lipid microspheres (about the size of a red blood cell) that circulate in the bloodstream to reflect ultrasound waves.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: HMIgFUSExperimental treatment 1 intervention
Group B: HMIgLIFUExperimental treatment 2 interventions
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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Columbia University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov