At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
OTL38 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
In Brief
A Phase 2 clinical trial evaluating OTL38, Near infrared camera imaging system, and 1 other intervention for Ovarian Cancer. Completed, enrolled 48 participants across 4 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesUnited States
CollaboratorsSynteractHCR
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedDec 2014
Primary CompletionNov 2015
TodayJul 2026
First PostedDec 16, 2014
Enrollment StartDec 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.5 years ago
Interventions
OTL38drug
Near infrared camera imaging systemdevice
Near infrared camera imaging system
Laparotomyprocedure
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery