Trials / Completed
CompletedNCT04241315
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- On Target Laboratories, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTL38 for Injection | Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL |
| DEVICE | Near infrared camera imaging system | Near infrared camera imaging system |
Timeline
- Start date
- 2020-03-26
- Primary completion
- 2021-10-07
- Completion
- 2021-11-01
- First posted
- 2020-01-27
- Last updated
- 2023-03-23
- Results posted
- 2023-03-23
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04241315. Inclusion in this directory is not an endorsement.