drugset / Trial / NCT04241315
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pafolacianine | Diagnostic / imaging agent | — | Intravenous |