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

Breast Cancer

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

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a portable ultrasound scan (done at the point of care — right in the clinic) to standard breast symptom assessment can improve the accuracy of detecting whether a breast concern is likely benign or cancerous, helping clinicians decide on the best next step for each patient. **You may be eligible if...** - You are a woman aged 18 or older - You have been referred for breast imaging because of a suspected breast problem or concern about possible cancer **You may NOT be eligible if...** - You are unable to understand study information due to language barriers or significant cognitive problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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