drugset / Trial / NCT02872701

OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

NCT02872701 ↗

Phase 2 Completed 100 enrolled On Target Laboratories, LLC Medelis Inc. · collab
NaSingle-groupOpen-labelDiagnostic

Summary

This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission tomography imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.

Timeline

Start
2017-05-04
Primary completion
2018-10-31
Completion
2018-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject pafolacianine Diagnostic / imaging agent — Intravenous

Indications