At a glance
ClinicalIndex Comparison Record- ✓Female patients 18 years of age and older
- ✓Primary diagnosis or high clinical suspicion of primary epithelial ovarian cancer planned for primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
- ✓Scheduled for laparotomy for debulking surgery, or laparoscopy with pre-authorization to convert to laparotomy if cancer detected
- ✓Negative serum pregnancy test at screening and negative urine pregnancy test on day of surgery
- ✕Previous exposure to OTL38
- ✕Known FR-negative ovarian cancer
- ✕Planned surgical debulking via laparoscopy or robotic surgery with no intent of laparotomy
- ✕Known ovarian cancer with miliary disease preoperatively determined to be inoperable
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
In Brief
A Phase 3 clinical trial evaluating OTL38, near infrared camera imaging system, and 1 other intervention for Ovarian Cancer. Completed, enrolled 140 participants across 11 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
Infrared imaging used to excite OTL38 for fluorescence
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery