Point-of-care ultrasound with AI to improve breast cancer screening
System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
We're testing whether short-trained nurses using AI-supported handheld ultrasound together with clinical breast exams can safely and accurately triage women aged 30+ without symptoms and women 18+ with breast symptoms in community settings in Arba Minch, Ethiopia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Arba Minch, Gamo Zone) |
| Trial ID | NCT07462351 on ClinicalTrials.gov |
What this trial studies
After a local awareness campaign, asymptomatic and symptomatic women are invited for screening beginning with a clinical breast exam; women with positive exams or symptoms receive targeted AI-supported point-of-care ultrasound (POCUS) at the complaint site. Clinical nurses or clinical officers perform the POCUS after a short training and certification program, while breast radiologists review images as the reference standard. In the first stage an expert radiologist is on site for comparison and safety monitoring, and if safety is confirmed the second stage proceeds without an on-site expert with remote radiologist review. Women with positive ultrasound findings or predefined alarming symptoms are referred for further follow-up and diagnostic work-up.
Who should consider this trial
Good fit: Ideal candidates are women aged 30 or older without breast symptoms for screening or women aged 18 or older with breast symptoms who can understand the study information and travel to sites in Arba Minch and the Gamo Zone.
Not a fit: Individuals who cannot comprehend the study information due to language barriers or cognitive impairment are excluded and will not be able to participate or benefit.
Why it matters
Potential benefit: If successful, this approach could speed detection and referral of suspicious breast findings and expand access to effective triage in low-resource communities.
How similar studies have performed: Prior pilot projects have shown that AI-assisted handheld breast ultrasound can help non-experts identify suspicious findings in low-resource settings, but larger confirmatory trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Asymptomatic women from the age of 30 with no upper age limit * Symptomatic women 18 years or older. Exclusion Criteria: * Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
Where this trial is running
Arba Minch, Gamo Zone
- Arba Minch University and health care facilities and markets in the Gamo Zone — Arba Minch, Gamo Zone, Ethiopia (Recruiting)
Study contacts
- Principal investigator: Kristina KL Lån g, MD PhD — Lund University
- Study coordinator: Kristina KL Lång, MD PhD
- Email: kristina.lang@med.lu.se
- Phone: +4640338880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.