drugset / Trial / NCT02997553

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

NCT02997553

Phase 3 Completed 744 enrolled Institut de Cancérologie de Lorraine
NaSingle-groupOpen-labelDiagnostic

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

Timeline

Start
2017-11-29
Primary completion
2022-09-19
Completion
2022-10-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 2.5 mg/ml Intravenous
Subject Technetium99 Unknown Subcutaneous