Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06932133

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unilabs Mammography Unit, Skane University Hospital

Malmö, 20502, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Point-of-care ultrasound

Diagnostic Test

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

Primary outcomes

  1. The area under the receiver operating characteristic curve (AUC) for the intervention, compared to that of the comparator

    Time frame: From the last enrolled participant to the end of one-year follow up

    • The AUC of POCUS compared to SoC
    • The AUC of AI compared to average radiologists on POCUS

Secondary outcomes

  1. The performance of POCUS and POCUS AI

    Time frame: From the last enrolled participants to the end of one year follow up

    • The sensitivity, specificity, PPV, and NPV of POCUS compared to SoC (Part 1)
    • The sensitivity, specificity, PPV, and NPV of POCUS compared to standard ultrasound (Part 1)
    • The sensitivity, specificity, PPV, and NPV of POCUS compared to mammography (Part 1)
    • The AUC of POCUS AI compared to SoC (Part 1)
    • The AUC, sensitivity, and specificity of POCUS in relation to tumor type, stage, breast density, previous history of breast cancer, age, and demographics (Part 1 and Part 2)
    • The AUC, sensitivity and specificity of POCUS AI in relation to tumor type, stage, breast density, previous history of breast cancer, age, and demographics (Part 1 and Part 2)
    • The sensitivity, specificity, PPV, and NPV of average radiologists on POCUS compared to standard ultrasound (Part 2)
    • The sensitivity and specificity of POCUS AI at different operating thresholds (Part 2)
    • The balanced accuracy of POCUS AI compared to average radiologists (Part 2)
    • The AUC, sensitivity, and specificity of POCUS AI

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Breast Point-of-Care Ultrasound Examination Trial

Acronym: Breast-POCET

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.