Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery.
Phase 3
Completed
- Conditions
- breast cancersentinel lymph node procedure1000629110043413
- Registration Number
- NL-OMON33334
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Women above the age of 21 who have biopsy-proven breast cancer stage I-II, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
Exclusion Criteria
Pregnant women, hyperthyroidism, significant renal (serum creatinin >= 400 µmol/L), cardiac or pulmonary disease (ASA III-IV), history of iodine allergy or analfylactic reaction to insect bites or medication.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Whether ICG enhanced NIRF imaging is able to detect sentinel lymph nodes as<br /><br>good as or better than the standard technique (technetium-99 labelled colloid<br /><br>and Patent Blue) during breast surgery in 97%± 2% of the cases. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The number of lymph nodes detected by ICG enhanced NIRF imaging during breast<br /><br>surgery. </p><br>