Using portable ultrasound and AI to assess breast symptoms
Breast Point-of-Care Ultrasound Examination Trial
This study is testing if using portable ultrasound with AI can help women with breast symptoms get accurate assessments for breast cancer in places where advanced imaging is hard to access.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Malmö) |
| Trial ID | NCT06932133 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of point-of-care ultrasound (POCUS) combined with artificial intelligence (AI) for assessing breast symptoms in women suspected of having breast cancer. It aims to determine if POCUS is as effective as standard diagnostic methods in low- and middle-income countries, where access to advanced imaging is limited. The trial consists of two parts: a prospective interventional study comparing POCUS to standard care and a retrospective study assessing POCUS and AI against radiologists' interpretations. The goal is to demonstrate that POCUS can provide reliable breast assessments and improve early diagnosis.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are referred for diagnostic imaging with suspected breast malignancy.
Not a fit: Patients who cannot understand the study information due to language barriers or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance early breast cancer detection in underserved populations.
How similar studies have performed: Other studies have shown promise in using POCUS for breast assessments, but the combination with AI for this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women (≥18 years of age) referred to diagnostic imaging with a suspicion on malignancy Exclusion Criteria: * Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
Where this trial is running
Malmö
- Unilabs Mammography Unit, Skane University Hospital — Malmö, Sweden (Recruiting)
Study contacts
- Principal investigator: Kristina Lång, MD PhD — Lund University, Unilabs Mammography
- Study coordinator: Kristina Lång, MD PhD
- Email: kristina.lang@med.lu.se
- Phone: +46771407710
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.