Clinical trial · Interventional
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
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
NCT03180307CI-TRIAL-00056325completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparotomy | Procedure | — | UNRESOLVED |
| near infrared camera imaging system | Device | — | UNRESOLVED |
| OTL38 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- no fluorescent imaging
- description
- Patient injected with OTL38, but does not undergo fluorescent imaging
- interventionNames
- Drug: OTL38
- Procedure: laparotomy
- type
- EXPERIMENTAL
- label
- near infrared imaging arm
- description
- Patient injected with OTL38 and undergoes near infrared imaging
- interventionNames
- Drug: OTL38
- Device: near infrared camera imaging system
- Procedure: laparotomy
Primary outcomes (1)
- measure
- Efficacy Patient Level
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients 18 years of age and older * 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 surgery, and: * Who are scheduled to undergo laparotomy for the debulking surgery OR * Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy * A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential * Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion * Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments Exclusion Criteria: * Previous exposure to OTL38 * Known FR-negative ovarian cancer * Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy. * Patients with known ovarian cancer miliary disease determined preoperatively to be inoperable. * Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient * History of anaphylactic reactions * History of allergy to any of the components of OTL38, including folic acid * Pregnancy or positive pregnancy test * Clinically significant abnormalities on electrocardiogram (ECG) * Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Impaired renal function defined as eGFR\< 50 mL/min/1.73m2 * Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin. * Known Stage IV ovarian cancer with brain metastases * Received an investigational agent in another clinical trial within 30 days prior to surgery * Known sensitivity to fluorescent light
References
Publications (1)
- DERIVEDTanyi JL, Randall LM, Chambers SK, Butler KA, Winer IS, Langstraat CL, Han ES, Vahrmeijer AL, Chon HS, Morgan MA, Powell MA, Tseng JH, Lopez AS, Wenham RM. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006). J Clin Oncol. 2023 Jan 10;41(2):276-284. doi: 10.1200/JCO.22.00291. Epub 2022 Sep 7. PMID 36070540