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

NCT07427407 | Not Yet Recruiting FDA Device

• 2 other identifiers: AURA-US-MD-CUMC-2026#AAAV4964
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Successful Identification of Breast Biopsy Marker

  Whether the investigational software identifies the location of a previously placed standard-of-care breast biopsy marker during ultrasound imaging.

  During the ultrasound imaging examination (single imaging session; approximately 5-10 minutes)

Study Arms (1)

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.

Device: Breast Ultrasound Imaging With Investigational AI Software

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.

Single Observational Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult female patients receiving routine clinical care for breast tumors at an academic medical center. Participants are recruited from patients undergoing standard-of-care breast ultrasound imaging as part of their clinical treatment pathway. The study aims to include a broad range of patients and does not restrict participation based on breast size, breast density, race, ethnicity, or other demographic characteristics, in order to capture diverse imaging presentations representative of real-world clinical practice.

You may qualify if:

• Participant can understand and sign informed consent documentation
• Participant has a previous placement of one of the standard-of-care breast biopsy markers

You may not qualify if:

• Previous breast cancer surgery in the region of interest
• Life expectancy \<6 months
• Allergy and/or hypersensitivity to titanium and/or nickel and/or ultrasound gel
• Carcinoma unknown primary
• Patient does not accept ultrasound examinations
• Patient with skin disease of areas to be examined (breast and/or axillary)

Sponsors & Collaborators

• AURA Health Technologies: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)