Status:

RECRUITING

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

Lead Sponsor:

Region Skane

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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 ultrasoun...

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. ...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

April 7 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT06932133

Start Date

April 7 2025

End Date

August 1 2026

Last Update

April 29 2025

Active Locations (1)

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Unilabs Mammography Unit, Skane University Hospital

Malmo, Sweden, 20502