USClinicalTrials.govClinical trialPhase 1Recruiting
Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Official record
- Identifier
NCT05219695- Recruiting locations
country
United States- Interventions studied
- Harmonic motion imaging guided focused ultrasound (HMIgFUS)Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)Microbubbles
- Lead sponsor
- Columbia University
- Target enrolment
- 82 participants
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Status
- Recruiting
- First posted
- Feb 2, 2022
- Last updated on the registry
- Aug 13, 2026
- Age
- 18 Years
- Sex
- FEMALE
- Study contact
- The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.
- Eligibility criteria
Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.
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.
- Indexed under
- Breast Cancer