Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery (GASVERT)

Institut de Cancérologie de Lorraine

Status and phase: Completed; Phase 3

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

Treatments: Drug: Indocyanine green; Device: Optonuclear probe; Drug: Technetium99; Device: Quest Camera

Study type: Interventional

Funder types: Other

Identifiers

NCT02997553

2016-A00799-42

Details and patient eligibility

About

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

Enrollment: 744 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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744 participants in 1 patient group

sentinel lymph node detection

Experimental group

Description:

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.

Treatment:

Device: Optonuclear probe

Drug: Technetium99

Drug: Indocyanine green

Device: Quest Camera