Evaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Sentinel Lymph Node (SLN) Detection in Breast Cancer: a Technical Feasibility Study

Completed

• Conditions: breast cancer; sentinel node procedure; 10006291; 10043413

• Registration Number: NL-OMON31831
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Women above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.

Exclusion Criteria

Pregnant women, significant renal (creatinine >, cardiac, or pulmonary disease (ASA III-IV), History of iodine allergy or anaphylactic reactions to insect bites or medication, presence or history of hyperthyroidism.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>• Ergonomics and function of the imaging system - the NIRF imaging system<br /><br>should not interfere with the standard Sentinel Lymph Node mapping procedure<br /><br>and used safely by the surgeon while detection of ICG takes place. Duration:<br /><br>1,5 hour clinical procedure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>• The secondary endpoint of this feasibility study is the number and location<br /><br>of detected sentinel lymph nodes compared to the standard detection of sentinel<br /><br>lymph nodes with the use of patent blue and technetium-99 labelled colloid.</p><br>