Recruiting
Phase 1

HMI

Sponsor:

Columbia University

Code:

NCT05219695

Conditions

Fibroadenoma

Breast Cancer Stage I

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Harmonic motion imaging guided focused ultrasound (HMIgFUS)

Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)

Microbubbles

Study Details

Brief summary:

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.

Conditions

Fibroadenoma

Breast Cancer Stage I

Study ID

NCT05219695

Start date

Jan 19, 2022

Status verified date

Aug, 2026

Completion date

May, 2031

Anticipated

Primary completion date

May, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Focused Ultrasound Surgery

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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.

Microbubble-mediated LIFU, i.e., sonoporation

Inclusion criteria:

  • Women 18 years or older
  • Deemed eligible to receive neoadjuvant systemic therapy as per the treating physician, with the dose and schedule deemed appropriate by the treating physician
  • Any stage invasive breast cancer provided the primary breast tumor size is at least 4 mm

Exclusion criteria:

  • Pregnant or lactating
  • Presence of breast implants
  • History of laser or radiation therapy to the affected breast
  • Contraindication history or hypersensitivity to ultrasound contrast agents, e.g., Definity, including polyethylene glycol (PEG) allergy.

Study Design

Enrollment

82 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Harmonic 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.

Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)

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

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.

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) ]
  • R2 value of ablated lesion depth [ Time Frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week) ]
  • R2 value of ablated lesion width [ Time Frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week) ]
  • R2 value of ablated lesion area [ Time Frame: From the date of ablation and imaging to the date of pathological results (approximately 1 week) ]

Central Contacts and Locations

Central contacts

Shiqi Hu, MSc

917-664-5382sh4193@columbia.edu

Locations

Columbia University Irving Medical Center/NYP

Recruiting

New York, New York, United States, 10032

Contacts

Shiqi Hu, MSc

917-664-5382sh4193@columbia.edu

Principal Investigator:

Bret Taback, MD

More Information

Sponsor

Columbia University

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-13.