Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05219695
Phase
PHASE1
Status
Recruiting
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Conditions

  • Breast Cancer Stage I
  • Fibroadenoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Harmonic motion imaging guided focused ultrasound (HMIgFUS) — PROCEDURE
    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.
  • Microbubble-mediated Low Intensity Focused Ultrasound (LIFU) — PROCEDURE
    Microbubble-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 — DRUG
    Definity 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.

Study Details

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.

Key Dates

First listed
Feb 2, 2022
Start date
Jan 19, 2022
Status verified
Aug 2026
Primary completion
May 31, 2031
Completion
May 31, 2031

Study Design

Enrollment
82 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: HMIgFUS
    Each study participants' tumors will be imaged using Harmonic Motion Imaging (HMI), an ultrasound elastography method. A central portion of the tumor will then be ablated and monitored using Harmonic Motion Imaging guided Focus Ultrasound (HMIgFUS). Only one portion of the tumor will be ablated; the other portions of the tumor, including tumor margins, will not be ablated. Following ablation, the tumor will be imaged again using HMI.
  • Experimental: HMIgLIFU
    Eligible participants have early-stage breast cancers and are scheduled to receive neoadjuvant chemotherapy as part of their clinical care. On the day of chemotherapy infusion, elasticity images of the lesions and surrounding tissues will be collected using HMI before infusion after tumor identification on ultrasound imaging. Within an hour after infusion, the participants' tumors will be treated with microbubble-mediated Low-Intensity Focused Ultrasound (LIFU), i.e. sonoporation.

Primary Outcome Measure

Number of patients with ablation [ Time Frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NYPNew YorkNew York10032
Shiqi Hu, MSc
[email protected]
917-664-5382
Bret Taback, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center/NYP· New York, NY

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