Clinical trial · Interventional
OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
A Pilot, Single Dose, Open-Label Study of OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
NCT04941378CI-TRIAL-00059307withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to sponsor request
Summary
Brief summary (as posted)
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative imaging camera system | Device | — | UNRESOLVED |
| OTL38 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OTL 38
- description
- The study drug in question is an Investigational New Drug (IND), folate analog ligand conjugated with an indole cyanine green-like dye called OTL38. There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, completed at least 1 hour prior to intraoperative imaging
- interventionNames
- Drug: OTL38
- Device: intraoperative imaging camera system
Primary outcomes (1)
- measure
- Compare the performance of different camera imaging systems in assessing the positive predictive values
- timeFrame
- Up to 4 weeks post surgery (completion of post-operative follow-up visit)
- description
- The primary objective of the study is to compare the performance of different camera imaging systems in assessing the sensitivity and positive predictive value of OTL38 to detect folate positive ovarian cancers using the gold standard of pathologic review.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients \> 18 years of age * Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer * Good operative candidate as determined by clinical presentation and laboratory assessments * Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: * Pregnant women as determined by urinary or serum beta hCG. * Patients with a history of allergy to any of the components of OTL38, including folic acid * Known FR-negative ovarian cancer * Patients with a known allergy to Benadryl * Previous exposure to OTL38 * Vulnerable populations: the homeless, prisoners or not capable of participating in the consent process
References
Publications (0)
Data not yet available
No reference posted for this study.