RecruitingNot ApplicableNCT06932133

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

Breast Point-of-Care Ultrasound Examination Trial


Sponsor

Region Skane

Enrollment

600 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • Women (≥18 years of age) referred to diagnostic imaging with a suspicion on malignancy

Exclusion Criteria1

  • Individuals unable to comprehend the study information due to language barriers or cognitive impairments.

Interventions

DIAGNOSTIC_TESTPoint-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

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NCT06932133


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