What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Artificial intelligence (AI) decision-support tool. The registry lists allocation as randomized. The goal of this clinical trial is to compare patient-centered outcomes when screening digital breast tomosynthesis (DBT) exams are interpreted with versus without a leading FDA-cleared artificial intelligence (AI) decision-support tool in real-world U.S.
They plan to enroll about 400,000 people at 6 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Interventions: Artificial intelligence (AI) decision-support tool
Primary outcome (registry wording): Cancer detection rate