Studying Artificial Intelligence in Breast Cancer Screening
Summary
- Sylvester Comprehensive Cancer Center will co-lead a clinical trial to evaluate whether artificial intelligence (AI) can help support radiologists in interpreting mammograms.
- The study will involve hundreds of thousands of mammograms using the AI support tool Transpara by ScreenPoint Medical.
- PRISM is patient-centered and developed in close partnership with patient advocates, clinicians, health system leaders and policymakers.
Sylvester Comprehensive Cancer Center, part of University of Miami Miller School of Medicine, will co-lead a newly funded, multi-institutional clinical trial to evaluate whether artificial intelligence (AI) can help support radiologists in interpreting mammograms more accurately.
The goal of the study is to improve breast cancer screening and reduce unnecessary callbacks and anxiety for patients.
The study, known as the PRISM Trial (Pragmatic Randomized Trial of Artificial Intelligence for Screening Mammography), is supported by a $16 million award from the Patient-Centered Outcomes Research Institute (PCORI). The study will involve hundreds of thousands of mammograms interpreted at academic medical centers and breast imaging facilities in California, Florida, Massachusetts, Washington and Wisconsin. The AI support tool studied will be Transpara by ScreenPoint Medical, with clinical workflow integration provided by the Aidoc aiOS platform.
“As the first major randomized trial of AI in breast cancer screening in the U.S., this study represents a pivotal step,” said Jose Net, M.D., director of breast imaging services at Sylvester, associate professor of clinical radiology at the Miller School and co-principal investigator of the study. “Our goal is to rigorously and objectively assess AI’s impact, identifying who benefits and who may not. Radiologists remain firmly in control of all diagnostic decisions.”
A Pressing Question in Breast Cancer Care
Breast cancer remains one of the leading causes of cancer death among women in the U.S. While routine mammography screening reduces mortality through early detection, it also has drawbacks, including false positives that can lead to unnecessary testing, anxiety and costs, and missed cancers.
“While AI offers substantial promise, it also prompts critical questions,” said Dr. Net. “Our focus is on understanding whether AI genuinely enhances cancer detection by radiologists or simply leads to more false alarms.”
What makes PRISM different is its emphasis on patient-centered research. The trial was developed in close partnership with patient advocates, clinicians, health system leaders and policymakers.
Our goal is to rigorously and objectively assess AI’s impact, identifying who benefits and who may not. Radiologists remain firmly in control of all diagnostic decisions.
Dr. Jose Net
Each participating facility will continue routine screening as usual, with no changes to the patient experience. Mammograms will be randomly assigned to be interpreted either by a radiologist on their own or with assistance from an FDA-cleared AI support tool. In all cases, a radiologist reads the exam and makes the final decision.
“A trial of this magnitude focusing on AI in breast cancer screening has never been conducted in the U.S.,” said Dr. Net. “The findings will influence not only clinical practices but also insurance policies, technology integration and patient interactions.”
Assessing AI’s True Impact
According to Dr. Net, few rigorous studies have assessed AI’s actual impact in this setting.
“This trial presents an opportunity to produce reliable evidence with a strong emphasis on the patient’s perspective,” he said.
In addition to analyzing cancer detection and recall rates, the study will include focus groups and surveys to capture how patients and radiologists perceive and trust AI-assisted care.
Dr. Net emphasized that the goal is not to replace human expertise but to understand how AI might complement it.
“Our skilled radiologists will always have the final say,” he said. “While AI can serve as a helpful assistant, it is ultimately the radiologist who is in control.”
The trial is expected to inform future policy decisions, best practices in screening and how to most effectively integrate emerging technologies into patient care.
In addition to Sylvester, the PRISM trial brings together six other leading academic medical centers:
• UCLA Health
• UC Davis Medical Center
• Boston Medical Center
• UC San Diego Health
• University of Washington Medical Center
• University of Wisconsin Health
Tags: AI, artificial intelligence, breast cancer, cancer research, clinical trials, Dr. Jose Net, mammography, Sylvester Comprehensive Cancer Center, technology