NCT05219695 Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
| NCT ID | NCT05219695 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Columbia University |
| Condition | Fibroadenoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-01-19 |
| Primary Completion | 2031-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 82 participants in total. It began in 2022-01-19 with a primary completion date of 2031-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Bret Taback, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05219695 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fibroadenoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05219695 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05219695 currently recruiting?
Yes, NCT05219695 is actively recruiting participants. Contact the research team at sh4193@columbia.edu for enrollment information.
Where is the NCT05219695 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05219695 clinical trial?
NCT05219695 is sponsored by Columbia University. The principal investigator is Bret Taback, MD at Columbia University. The trial plans to enroll 82 participants.