Prospective Ultrasound Data Collection Study for AI-Based Detection of Breast Biopsy Markers

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

Sponsor
AURA Health Technologies
Study ID
NCT07427407
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Breast Ultrasound Imaging With Investigational AI Software — DEVICE
    An FDA-cleared breast ultrasound system with an AI investigational software used for data collection in this observational study. Use of the device does not alter standard clinical care.

Study Details

The goal of this observational study is to collect ultrasound imaging data to support the development and refinement of an artificial intelligence (AI)-enhanced ultrasound software designed to detect and localize standard-of-care breast biopsy markers in adult female patients undergoing surgical excision of a breast tumor. The main questions it aims to answer are: Can the study software identify the location of previously placed breast biopsy markers during routine ultrasound examinations? Participants will undergo limited breast ultrasound imaging during a standard-of-care scheduled clinical visit. During the ultrasound imaging, the ultrasound system will automatically record the ultrasound images for the development and training of the AI software The study does not change standard medical care, and no diagnostic or treatment decisions are made based on the study software.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Single Observational Cohort
    Adult female patients undergoing routine breast ultrasound imaging in a clinical care setting who have a previously placed standard-of-care breast biopsy marker.

Primary Outcome Measure

Successful Identification of Breast Biopsy Marker [ Time Frame: During the ultrasound imaging examination (single imaging session; approximately 5-10 minutes) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Katja Pinker-Domenig, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Columbia University Irving Medical Center· New York, NY

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