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A Trial on the Use of Point-of-care Ultrasound in the Assessment of Breast Symptoms

RECRUITINGN/ASponsored by Region Skane
Actively Recruiting
PhaseN/A
SponsorRegion Skane
Started2025-04-07
Est. completion2025-08
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06932133

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions2

Breast CancerCancer

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