Breast Cancer AI Imaging Study

Elucidating the Impact of Social Wellness and Artificial Intelligence on the Psychological Consequences of Breast Cancer Imaging

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Cancer Screening

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 Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled online from across the US.

Potential participants will not be screened for eligibility. In the informed consent process, participants will self-disclose if they have done breast cancer imaging at a US institution.

Pregnant women may choose to participate in the repository.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Dexter Hadley, M.D., PhD, M.S.E, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; AI; Artifical Inteligence
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: STUDY00005494

Drug and device information, study documents

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