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NCT02872701 · ClinicalTrials.gov registry record · Phase 2
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
A Phase 2 study, sponsored by On Target Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT02872701: Completed Phase 2 study, sponsored by On Target Laboratories.
NCT02872701 is a Phase 2 study that has completed, run by On Target Laboratories. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02872701, a Phase 2 study, has completed, sponsored by On Target Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive tissue samples (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be FR+ and lung cancer by central pathology relative to the total number of tissue samples confirmed to be FR+ and lung cancer by central pathology. Sensitivity = (True Positive)/(True Positive +False Negative)
Interventions
- DRUG OTL38 for Injection
- DEVICE Near infrared camera imaging system
- PROCEDURE Endoscopic or Thoracic Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-05-04 |
| Est. Completion | 2018-11-30 |
| Phase | Phase 2 |
What the finished NCT02872701 record still lists
NCT02872701 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 3 interventions - of which OTL38 for Injection is the first listed.
NCT02872701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02872701 about?
NCT02872701 is a clinical study titled "OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules". 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 I...
What is the current status of trial NCT02872701?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2017-05-04. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT02872701?
The interventions under investigation include: OTL38 for Injection (DRUG), Near infrared camera imaging system (DEVICE), Endoscopic or Thoracic Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT02872701?
This trial is sponsored by On Target Laboratories, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02872701's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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