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NCT03180307 · ClinicalTrials.gov registry record · Phase 3
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
A Phase 3 study, sponsored by On Target Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
NCT03180307: Completed Phase 3 study, sponsored by On Target Laboratories.
NCT03180307 is a Phase 3 study that has completed, run by On Target Laboratories. The registered enrollment target is 140 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03180307, a Phase 3 study, has completed, sponsored by On Target Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
Study Summary
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
Primary Outcome
Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)
Interventions
- PROCEDURE laparotomy
- DRUG OTL38
- DEVICE near infrared camera imaging system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2018-01-26 |
| Est. Completion | 2020-10-16 |
| Phase | Phase 3 |
What the finished NCT03180307 record still lists
NCT03180307 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which laparotomy is the first listed.
NCT03180307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03180307 about?
NCT03180307 is a clinical study titled "OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer". This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
What is the current status of trial NCT03180307?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2018-01-26. Estimated completion is 2020-10-16.
What interventions are being tested in trial NCT03180307?
The interventions under investigation include: laparotomy (PROCEDURE), OTL38 (DRUG), near infrared camera imaging system (DEVICE).
Who is sponsoring clinical trial NCT03180307?
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 NCT03180307's enrollment target sits among peer trials
140 1565th of 2000 higher than 424 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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