This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery. 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
744
Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Non-inferiority of indocyanine green guided sentinel lymph node biopsy
The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively. Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.
Time frame: 1 day
Total number of sentinel lymph node detected
The total number of sentinel node detected will be assess by the two techniques
Time frame: 1 day
Number of false negative result
False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node
Time frame: 1 day
Allergic reactions
Percentage of patients with allergic reactions
Time frame: 8 days
Evaluation of pain
Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)
Time frame: 1 day
fluorescence imaging
The total number of sentinel node detected by fluorescence imaging
Time frame: 1 day
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