drugset / Trial / NCT07499674

Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung

NCT07499674 ↗

Phase 3 Recruiting 132 enrolled Vergent Bioscience, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase 3, multi-center, randomized and intrasubject controlled study to evaluate the safety and efficacy of abenacianine for injection, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer using NIR imaging in participants undergoing surgery for cancer in the lung. Approximately 132 partiipants will be enrolled to ensure a minimum of 115 evaluable participants receiving abenacianine and undergoing NIR imaging and a control group of 12 participants who will receive abenacianine but no NIR imaging.

Timeline

Start
2026-03-31
Primary completion
2026-12
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Abenacianine Diagnostic / imaging agent 0.31 mg/kg Intravenous

Indications