Breast Cancer AI Imaging Study

Recruiting

• Conditions: Breast Cancer; Breast Cancer Screening

• Registration Number: NCT06604078
• Lead Sponsor: University of Central Florida

Brief Summary

This study aims to develop a social health platform called MammoChat (https://MammoChat.com) that allows patients to share their real-world patient data to a trusted network for development of clinical intelligence to improve patient outcomes. Therefore:

1. The investigator will establish a Discourse social network where patients can anonymously and securely share their breast imaging and interact with other patients.

2. The investigator will use standardized questionnaires to understand the impact of use of the social network on outcomes related to breast cancer screening such as anxiety.

3. The investigator will assemble a crowdsourced, de-identified radiographic repository for training, testing, and validating AI models aimed at earlier and more accurate disease detection for breast cancer.

Detailed Description

With over 40,000,000 mammograms run annually in the US, there are psychological consequences of breast cancer imaging that are well documented among patients such as stress and anxiety from largely false positive or indeterminant readings by radiologists.

This UCF MammoChat platform is one of the first projects that engages patients to donate their breast cancer imaging in an effort to reduce the psychological consequences of breast cancer imaging using social networks and artificial intelligence.

This repository will be supported and maintained by the University of Central Florida College of Medicine (UCF COM) Clinical and Aerospace Research team. These clinical research coordinators will operate the repository, including administering patients, imaging sites and transfers through an administrative panel.

Study Timeline

• Study Start: 2024-09-05
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2075-09
• Study Completion: 2075-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Adults, ages 18 and older
• Had a radiographic breast cancer imaging test, either for screening or diagnosis of breast cancer, with either positive or negative results performed in a US institution.
• Have an email account with access to a reliable internet connection or smartphone

Exclusion Criteria

• Minors , ages under 18
• Prisoners. Given the repository design, prisoners are unlikely to participate and provide a consent
• Adults who are unable to provide consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AI Model Development	25 years	Train, test and validate AI models with de-identified radiographic images collected from participants.
Psychological Impact of Breast Cancer Screening	25 years	Assess user anxiety using the standardized COS-BC (Consequences of Screening in Breast Cancer) questionnaire.
Social Discourse for Patients on Wellness Network	25 years	Assess patient participation on Discourse social network using standardized user metrics such as activity logs, images posted, other interactions, etc.

Trial Locations

Locations (1)

University of Central Florida; 🇺🇸 Orlando, Florida, United States