Intra-operatieve fluorescente beeldvorming van schildwachtklieren bij vulva kanker.
Completed
- Conditions
- Vulvar Cancer
- Registration Number
- NL-OMON23796
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification rate, defined as the proportion of patients in whom sentinel and non-sentinel lymph nodes was identified percutaneously with the fluorescent signal of ICG:HSA.
- Secondary Outcome Measures
Name Time Method 1. Median number of lymph nodes identified with ICG:HSA and standard SNB;<br /><br>2. Identification rate of standard SNB;<br /><br>3. Sensitivity: Percentage of patients in whom fluorescent lymph nodes were identified of the total patients with identified sentinel lymph nodes by standard SNB technique;<br /><br>4. Improvement in false-negative rate.