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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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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.

Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)

Indocyanine green

Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.

Lymphoscintigraphy is performed to identify the sentinel node

Technetium99

The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.

Optonuclear probe

The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.

Quest Camera

MARCHAL FREDERIC, MD, PU-PH

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

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

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

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.

The total number of sentinel node detected will be assess by the two techniques

False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node

Percentage of patients with allergic reactions

Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)

The total number of sentinel node detected by fluorescence imaging

Institut de Cancérologie de Lorraine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery	NCT02997553	Breast Carcinom... Head and Neck C... Melanoma (Skin) Squamous Cell C... Cervix Cancer Endometrium Can... Ovary Cancer Vulva Cancer Anus Cancer Rectum Cancer	Indocyanine gre... Technetium99 Optonuclear pro... Quest Camera	18 Years -	Institut de Cancérologie de Lorraine
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery	NCT02997553	Breast Carcinom... Head and Neck C... Melanoma (Skin) Squamous Cell C... Cervix Cancer Endometrium Can... Ovary Cancer Vulva Cancer Anus Cancer Rectum Cancer	Indocyanine gre... Technetium99 Optonuclear pro... Quest Camera	18 Years -	Institut de Cancérologie de Lorraine

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