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

NCT06932133 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Point-of-care ultrasound

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

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Kristina Lång, MD PhD · Lund University, Unilabs Mammography

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2026-02-12
Completion
2027-02-12
FDA Device
Yes

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06932133 on ClinicalTrials.gov