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NCT02317705 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

A Phase 2 study, sponsored by On Target Laboratories.

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT02317705: Completed Phase 2 study, sponsored by On Target Laboratories.

NCT02317705 is a Phase 2 study that has completed, run by On Target Laboratories. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02317705, a Phase 2 study, has completed, sponsored by On Target Laboratories.

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

This study is being done to: * test the safety of OTL38 * see if OTL38 helps light up the cancer when viewed with the special camera system * test the safety of the special camera system for use along with OTL38 during surgery

Primary Outcome

Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.

Interventions

  • PROCEDURE Laparotomy
  • DEVICE Near infrared camera imaging system
  • DRUG OTL38

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2014-12
Est. Completion 2015-11
Phase Phase 2
On Target Laboratories

4 total trials

What the finished NCT02317705 record still lists

NCT02317705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

The record links to 0 conditions, and to 3 interventions - of which Laparotomy is the first listed.

NCT02317705 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02317705 about?

NCT02317705 is a clinical study titled "Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer". This study is being done to: * test the safety of OTL38 * see if OTL38 helps light up the cancer when viewed with the special camera system * test the safety of the special camera system for use along with OTL38 during surgery

What is the current status of trial NCT02317705?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2014-12. Estimated completion is 2015-11.

What interventions are being tested in trial NCT02317705?

The interventions under investigation include: Laparotomy (PROCEDURE), Near infrared camera imaging system (DEVICE), OTL38 (DRUG).

Who is sponsoring clinical trial NCT02317705?

This trial is sponsored by On Target Laboratories, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02317705's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 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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Source: ClinicalTrials.gov NCT02317705, the US trial registry maintained by the National Library of Medicine. NCT02317705 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.