sing optical spectroscopy for the detection of positive resection margins for invasive ductal carcinoma and ductal carcinoma in situ during breast conserving surgery

• Conditions: Breast cancer; ductal carcinoma in situ; invasive carcinoma; 10006295

• Registration Number: NL-OMON48369
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 193

Inclusion Criteria

Women undergoing breast conserving surgery, with or without previous treatment
with neo-adjuvant chemotherapy

Exclusion Criteria

Suspected oversensitivity to light; e.g. patient who has had photodynamic
therapy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>In this non-randomized controlled trial study we want to investigate the<br /><br>accuracy of optical spectroscopy for the intra-operative detection of positive<br /><br>resection margins during breast conserving surgery. The main endpoint of this<br /><br>research will be the sensitivity and specificity of DRS for the detection of<br /><br>measurement locations that are positive for IDC or DCIS according to<br /><br>histopathologic evaluation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We furthermore want to assess the usability of optical spectroscopy for<br /><br>intra-operative guidance. For this secondary study parameter we intend to use<br /><br>the System Usability Scale (SUS-score). </p><br>