Gerandomiseerde vergelijking tussen indocyanine groen en indocyanine groen gekoppeld aan humaan serum albumine bij intra-operatieve fluorescente beeldvorming van schildwachtklieren bij borstkankerpatienten.
Completed
- Conditions
- Breast cancer
- Registration Number
- NL-OMON21588
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Breast 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 Signal-to-background ratio of identified SLNs, defined as the fluorescence intensity of SLN divided by the fluorescence intensity of the surrounding background.
- Secondary Outcome Measures
Name Time Method 1. Number of identified SLNs: fluorescence and non-fluorescence;<br /><br>2. In vivo and ex vivo fluorescence intensity of SLNs;<br /><br>3. Identification ratio;<br /><br>4. Percutaneous lymphatic channel identification;<br /><br>5. Time to identification of SLN.