NCT07462351

System-integrated Point-of-Care Ultrasound in Breast Cancer Screening

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,800 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To assess the feasibility, safety, and clinical performance of community-based breast cancer screening incorporating clinical breast exam and short-termed trained examiners performing AI-supported breast POCUS for triage in limited-resource settings.

Detailed description

Following awareness campaign, asymptomatic and symptomatic women are invited to breast cancer screening. The screening intervention consists initially of clinical breast exam (CBE). Those that are positive at CBE or that present with symptoms are further examined with targeted artificial intelligence (AI)-supported breast point-of-care ultrasound (POCUS) on the complaint site. The AI-supported POCUS is performed by clinical nurses or clinical officers that have undergone a short training program and certification process in POCUS examination. In the first stage of the study, the same women will also be examined by an expert on site (breast radiologist). If clinical safety can be determined, the second stage of the study will start in which expert radiologist will not be on site. Ultrasound images will be assessed by breast radiologists that will serve as reference standard (on site in stage 1 and remotely in stage 2). Women positive at POCUS triage (positive ultrasound finding or with predefined alarming clinical symptoms) will be referred to further follow up.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI	AI-supported POCUS for triage

Timeline

• Start date: 2026-03-11
• Primary completion: 2026-05-23
• Completion: 2026-12-31
• First posted: 2026-03-10
• Last updated: 2026-04-13

Locations

1 site across 1 country: Ethiopia