Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery
NCT ID: NCT02997553
Last Updated: 2023-01-09
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
PHASE3
744 participants
INTERVENTIONAL
2017-11-29
2022-10-12
Brief Summary
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The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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sentinel lymph node detection
Each patient receive both injections of Technetium99 (standard care) and indocyanine green.
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
Indocyanine green
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
Technetium99
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.
Lymphoscintigraphy is performed to identify the sentinel node
Optonuclear probe
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
Quest Camera
The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
Interventions
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Indocyanine green
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
Technetium99
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.
Lymphoscintigraphy is performed to identify the sentinel node
Optonuclear probe
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
Quest Camera
The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* cancer histologically proved
* patient eligible for sentinel node detection
* contraceptive methods for men and women of childbearing age
* signed informed consent form
* patient affiliated to the social security system
Exclusion Criteria
* adenopathy (s) clinically suspicious or positively cytopenic
* women who are pregnant or breast-feeding
* associated pathology that may prevent patient of receive indocyanine green
* ongoing participation in another clinical trial with an investigational drug
* patients deprived of liberty or under supervision
* impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons
18 Years
ALL
No
Sponsors
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Institut de Cancérologie de Lorraine
OTHER
Responsible Party
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Principal Investigators
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MARCHAL FREDERIC, MD, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de Lorraine
Locations
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Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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2016-A00799-42
Identifier Type: -
Identifier Source: org_study_id
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