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COMPLETED
NCT02997553
PHASE3

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

Sponsor: Institut de Cancérologie de Lorraine

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

744

Start Date

2017-11-29

Completion Date

2022-10-12

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

Indocyanine green

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

DRUG

Technetium99

Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node

DEVICE

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.

DEVICE

Quest Camera

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

Locations (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France