Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Cancérologie de Lorraine

Criteria

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