Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.
NCT ID: NCT01982227
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2013-03-31
2014-12-31
Brief Summary
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Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries.
The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated.
This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.
Detailed Description
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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patients
Patients (Aged 18 to 70 inclusive) with progressive colorectal cancer in intra-abdominal surgery requiring resection +/- Chemotherapy Hyperthermic Intraperitoneal
indocyanine green
intravenous injection (0.25mg/kg) of the indocyanine green 24h before the surgery.
Interventions
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indocyanine green
intravenous injection (0.25mg/kg) of the indocyanine green 24h before the surgery.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 70 inclusive
* Signature information form and consent by the patient
Exclusion Criteria
* Contraindication to surgery
* Diagnosis not confirmed colorectal adenocarcinoma
* Persons major subject of legal protection or unable to consent
18 Years
70 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Gabrielle BARABINO, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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CHU de Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2012-004314-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1208138
Identifier Type: -
Identifier Source: org_study_id