drugset / Trial / NCT04719156

Fluorescent Intra-operative Tumor Margin Examination

NCT04719156

Phase 2 Recruiting 110 enrolled Kurt Weiss Stryker Nordic · collab
NaSingle-groupOpen-labelDiagnostic

Summary

Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.

Timeline

Start
2021-03-02
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 2 mg/kg Intravenous

Indications