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A Trial on the Use of Point-of-care Ultrasound in the Assessment of Breast Symptoms
Sponsor: Region Skane
Summary
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.
Official title: Breast Point-of-Care Ultrasound Examination Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-04-07
Completion Date
2027-02-12
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Point-of-care ultrasound
Point-of-care ultrasound will be performed on symptomatic breast patients. The images will be analysed by AI
Locations (1)
Unilabs Mammography Unit, Skane University Hospital
Malmo, Sweden