At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Single Dose, Open-Label, Exploratory Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
In Brief
A Phase 2 clinical trial evaluating OTL38 for Injection, Near infrared camera imaging system, and 1 other intervention for Lung Neoplasms and Lung Cancer. Completed, enrolled 100 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Near infrared camera imaging system
Endoscopic or Thoracic Surgery