NCT06932133

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

Breast Point-of-Care Ultrasound Examination Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this trial we want to understand if the use of POCUS is non-inferior to Standard of Care (SoC) and if the combination of POCUS AI can reach non-inferior performance to that of breast radiologists. There is a need for breast diagnostic tools in underserved countries since late-stage diagnosis is a major cause of the high breast-cancer mortality in low-and middle-income countries. Showing that POCUS can be sufficient for an assessment of focal breast symptoms can provide evidence for a broader use. Also, enabling automated interpretation using AI can add to the value of this low-cost and accessible solution. The first part of the trial is a prospective open-label accuracy study with paired design. The intervention of POCUS as a targeted diagnostic method for women with focal breast complaints will be compared with SoC. We will also be able to compare POCUS with the individual components of SoC (mammography and standard ultrasound) and retrospectively with POCUS AI. The second part of the trial is a single-blinded retrospective paired mulitcase multireader study. In this part we can directly assess POCUS and POCUS AI without the influence of mammography and benchmark to a larger group of radiologists and in addition compare with standard ultrasound

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Point-of-care ultrasound	Point-of-care ultrasound will be performed on symptomatic breast patients. The images will be analysed by AI

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-02-12
• Completion: 2027-02-12
• First posted: 2025-04-17
• Last updated: 2026-03-30

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study