Clinical validation of the optical mammography system

Completed

• Conditions: 10006291; breast cancer; breast neoplasms

• Registration Number: NL-OMON30324
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

BIRADS 2-5 on X-ray mammography
Patients should have both breasts
Age > 18 years

Exclusion Criteria

recent breast biopsy/fine needle aspiration

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number and size of lesions and location within the breast will be recorded. The<br /><br>characteristics concerning contrast intensity and direction (i.e. higher or<br /><br>lower signal compared to background), and homogeneity will be scored for each<br /><br>lesion. The nature of the lesions (malignant/benign) will be determined by<br /><br>MR-mammography, and, if necessary, pathology report (reference standard).<br /><br>The safety of the PMS DOT system will also be assessed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>