Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

Study Overview
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Brief Summary
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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

Official Title
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Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

Conditions
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Breast Carcinoma, Head and Neck Cancer, Melanoma (Skin), Squamous Cell Carcinoma, Skin, Cervix Cancer, Endometrium Cancer, Ovary Cancer, Vulva Cancer, Anus Cancer, Rectum Cancer

Intervention / Treatment
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* Drug: Indocyanine green
* Drug: Technetium99
* Device: Optonuclear probe
* Device: Quest Camera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years 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: neoadjuvant chemotherapy or hormone therapy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sentinel lymph node detection<br>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. | Drug: Indocyanine green<br>* Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)<br>* Other names: Infracyanine;Drug: Technetium99<br>* Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node<br>* Other names: NANOCIS;Device: Optonuclear probe<br>* The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.<br>Device: Quest Camera<br>* The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of sentinel lymph node detected | The total number of sentinel node detected will be assess by the two techniques | 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 | 1 day | 
| Allergic reactions | Percentage of patients with allergic reactions | 8 days | 
| Evaluation of pain | Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain) | 1 day | 
| fluorescence imaging | The total number of sentinel node detected by fluorescence imaging | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine green (ICG), Sentinel lymph node biopsy, Technetium99, Tumors, Optonuclear probe, Surgery