Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine gree
Not Applicable
Completed
- Conditions
- Ovarian cancerCancer
- Registration Number
- ISRCTN16945066
- Lead Sponsor
- eiden University Medical Center (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
1. All patients diagnosed with or suspected for ovarian cancer planned for staging or cytoreductive surgery
2. Age >18 years old
Exclusion Criteria
1. Renal impairment (defined as eGFR<55)
2. History of allergy to iodine, shellfish or indocyanine green
3. Patient pregnant or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of intraoperative detected metastases using near-infrared fluorescence imaging and indocyanine green.This will be measured during surgery. When new anatomical sites are exposed during surgery, color images and NIR fluorescent images are obtained. After surgery, the Pathologist will perform histological assessment of the resected lesions for tumor status.
- Secondary Outcome Measures
Name Time Method 1. Sensitivity and specificity of detected fluorescent hotspots<br>2. Concordance between fluorescence signal and pathology assessment<br><br>Sensitivity and specificity of the fluorescent signal will be calculated after tumor status of theresected lesions is assessed. Concordance will also be calculated after surgery with theobtained information on fluorescence signal and tumor status of the resected lesions.