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

A Prospective, Non-Interventional, Observational Study to Collect Ultrasound Imaging Data for the Development of an AI-Based Software for the Detection and Visualization of Breast Biopsy Markers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Breast Ultrasound Imaging With Investigational AI Software

Detailed Description

Study Design and Setting

This is a prospective, non-interventional observational study designed to collect ultrasound imaging data and related metadata to support the development, refinement, and performance characterization of an artificial intelligence (AI)-enhanced ultrasound software intended to detect and localize standard-of-care breast biopsy markers.

All ultrasound examinations are performed as part of routine clinical care for patients undergoing evaluation and planned surgical excision of a breast tumor. Study participation does not alter standard imaging protocols, clinical workflow, or treatment decisions.

Study Procedures

During a scheduled clinical visit, participants undergo limited B-mode breast ultrasound imaging using an FDA-cleared ultrasound system provided for the study. The system includes investigational software that displays marker localization output during image acquisition. The software output is not used to guide or alter clinical decision-making.

Ultrasound image data are automatically recorded by the system during the examination. Imaging datasets include visualization of the biopsy marker and surrounding breast tissue. When applicable, imaging may occur at different time points along the surgical treatment pathway.

A brief user-experience questionnaire may be completed by the operating physician following image acquisition. De-identified clinical and imaging metadata are recorded in a structured case report form (CRF).

Data Collection and Management

Ultrasound image data are de-identified prior to transfer. De-identified datasets are securely transmitted to the sponsor's controlled research environment for algorithm development and analysis.

Collected variables may include imaging parameters, marker type, breast tissue characteristics, tumor characteristics, and operator experience level. A structured data dictionary defines all variables collected, including source, format, allowable ranges, and coding conventions where applicable.

All study data are stored in compliance with applicable data protection and privacy regulations. Access to study data is restricted to authorized personnel.

Quality Assurance and Monitoring

Data quality procedures include predefined validation checks for completeness, internal consistency, and logical range limits within the electronic data capture system. Automated and manual data review processes are implemented to identify missing, inconsistent, or out-of-range values.

Source data verification may be performed on a risk-based sample of records to confirm consistency between recorded study data and source documents, such as medical records or ultrasound system exports.

Standard Operating Procedures (SOPs) govern study conduct, including patient recruitment, data acquisition, data transfer, data management, adverse event documentation, and change management. Monitoring activities may be conducted according to a risk-based plan.

Statistical Considerations

This study is primarily descriptive and developmental in nature. Analyses will focus on characterization of software marker localization performance, including measures such as detection success, time to localization, and performance across relevant subgroups (e.g., tissue characteristics, operator experience levels).

Agreement analyses may be performed comparing software output to trained reader assessments of recorded ultrasound images. Statistical methods may include descriptive statistics, confidence interval estimation, and exploratory subgroup analyses. The study is not designed as a confirmatory clinical effectiveness trial.

Sample Size Rationale

The planned enrollment is based on feasibility considerations and the need to collect a sufficient number of imaging datasets to support algorithm development and performance characterization across a range of clinical and anatomical conditions. The study is not powered for confirmatory hypothesis testing.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
      • Principal Investigator: Katja Pinker-Domenig, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: AURA Health Technologies

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: AURA-US-MD-CUMC-2026; #AAAV4964 (Other Identifier: Columbia University Irving Medical Center IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No