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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN16945066 |
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Date of registration:
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11/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green
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Scientific title:
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Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green: a open-label, exploratory, non-randomised clinical trial |
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Date of first enrolment:
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01/10/2012 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN16945066 |
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Study type:
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Interventional |
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Study design:
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Open-label exploratory non-randomised clinical trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Alexander
Vahrmeijer |
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Address:
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Albinusdreef 2
2333 ZA
Leiden
Netherlands |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian cancer
Cancer
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Intervention(s)
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Intravenous administration of 20 mg Indocyanine Green
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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1. Sensitivity and specificity of detected fluorescent hotspots
2. Concordance between fluorescence signal and pathology assessment
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.
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Source(s) of Monetary Support
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Leiden University Medical Center (Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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