Intraoperatieve detectie van de schildwachtklier met indocyanine groen gecombineerd met radioactief Nanocoll bij vulva kanker patienten.
Recruiting
- Conditions
- Vulvar cancer
- Registration Number
- NL-OMON20197
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Vulvar cancer patients planned to undergo a sentinel lymph node procedure.
Exclusion Criteria
1. History of allergy to iodine, shellfish, indocyanine green or human serum albumin;
2. Pregnancy;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The proportion of patients in whon sentinel and non-sentinel lymph nodes can be identified;<br /><br>2. Difference in signal-to-background ratio between different injection groups.
- Secondary Outcome Measures
Name Time Method 1. Carrelation between fluorescent and radioactove nodes;<br /><br>2. The correlation between the quantitative fluorescence signal and quantitative radioactive signal.