drugset / Trial / NCT04241315

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

NCT04241315 ↗

RandomizedParallel-groupOpen-labelDiagnostic

Summary

This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other 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
2020-03-26
Primary completion
2021-10-07
Completion
2021-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject pafolacianine Diagnostic / imaging agent — Intravenous

Indications