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NCT Number: NCT07214883

UCF MammoChat: Image Repository

This study aims to develop AI models to better read diagnostic mammograms for various populations and types of breast cancer, using the images that participants donate and their responses from study questionnaire to improve patient outcomes. This study also aims to provide mammography images to participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Central Florida

Orlando, Florida, 32827, United States

Location status: Recruiting

Location contact

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Britney-Ann Wray, BS, CCRP, CTBS

CONTACT

[email protected]

4072668742

Jane C Gibson, PhD

PRINCIPAL_INVESTIGATOR

About this study

Breast cancer patients often face overwhelming emotional and practical challenges, from feeling isolated to struggling to find the right information or resources during their treatment and recovery. These barriers can greatly impact both their quality of life and the effectiveness of their care. Among all US women, breast cancer is the second most common cancer and the second most common cause of cancer death. Recent guidelines recommend screening mammography in healthy women starting at 40 years old. The goal of screening mammography is to catch pre-cancerous lesions earlier so there is a high false positive error rate by design to not miss even remotely suspicious lesions on imaging. As evidenced by epidemiological studies, overdiagnosis in breast cancer is now a problem where up to 50% of screened women will have a false positive mammogram interpretation in their lifetime. The psychological impact of the false positivity manifest has significantly increased anxiety among patients that are needlessly recalled for false positive mammogram screening. Moreover, imprecise mammography interpretation may set off a complex cascade of potentially downstream surgical procedures (such as biopsy or mastectomy) for localized disease versus medical interventions such as radiation or chemotherapy for more advanced diseases.

The Health Insurance Portability and Accountability Act (HIPAA) gives patients the right to share their clinical data via informed consent for meaningful use such as research to improve health outcomes. One way of supporting breast cancer patients is by making their mammograms available to them. This allows patients to see and share their images. Some patients may be deterred from obtaining their images from their imaging centers due to cost and as they have no way to view DICOM images. Therefore, this study seeks to provide the mammography images to the participants.

While there are many open-source AI algorithms to improve precision in mammography interpretation, there are widely discrepant outcomes in breast cancer due to a complex and multifactorial disease etiology of different patient populations including social determinants of health. A recent retrospective study found that the integration of AI algorithms performed significantly better than the standard model for predicting breast cancer risk at 0 to 5 years 8. However, the bias in training data used to develop AI has long been recognized as limitations to its widespread application to marginalized populations as recently evidenced by a class action lawsuit against United Healthcare claiming its AI algorithms denied coverage and thus care to black and brown patients at scale 9,10. Moreover, the most cutting-edge algorithms in the current age of generative AI may often make random errors that can be disastrous in a clinical scenario. AI models are not omniscient as there is great variability in humans. AI models may need to be enhanced for different populations (such as different racial groups, ages ranges, or ethnicities) or for different types of breast cancer. Therefore, there is a stark need for accessible patient populations to demonstrate the applicability of robust AI to a diverse US population.

Therefore, using the images that the patients donate, the study aims to build AI models that can better read diagnostic mammograms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnant women may choose to participate.

Exclusion criteria

  • Minors , ages under 18
  • Prisoners
  • Adults who are unable to provide consent.

Treatment and study plan

No interventions

Other

No intervention for participants.

Primary outcomes

  1. AI model training using mammograms

    Time frame: 1 year

    Train, test and validate AI models with de-identified mammograms collected from imaging facilities.

  2. Provide mammography images to participants

    Time frame: 1 year

    Once images are received, participant will have access to view their mammograms.

Study contacts

Contact information is provided by the study sponsor or research team.

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Britney-Ann Wray, BS, CTBS, CCRP

CONTACT

[email protected]

4072668742

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

UCF MammoChat: An AI-Driven Platform for Personalized Breast Cancer Patient Support -Image Repository

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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