NCT02997553

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 744 (actual)
• Sponsor: Institut de Cancérologie de Lorraine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-29
• Primary completion: 2022-09-19
• Completion: 2022-10-12
• First posted: 2016-12-20
• Last updated: 2023-01-09

Locations

1 site across 1 country: France