The high cost of diagnostic equipment, limited expertise, and inadequate infrastructure are major barriers to early breast cancer diagnosis in low- and middle-income countries. Point-of-care ultrasound (POCUS) offers a relatively low-cost, portable solution that, when combined with artificial intelligence (AI)-driven image analysis, has the potential to significantly expand access to breast assessment in these settings. The purpose of this study is to evaluate the performance of POCUS for women with focal breast symptoms and to assess the performance of AI to analyze POCUS images. The study will be divided in two parts: a prospective interventional study and a retrospective multicase multireader study.
Protocol Amendment History
2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-10; most recent amendment 2026-03-27.
Status change: Recruiting → Active, Not Recruiting2026-03-27