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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
The purpose of this study is to see if OTL38 helps light up the cancer when viewed with the special camera system; to test the safety of OTL38 to see if participants can tolerate it; and to test the safety of the special camera system for use along with OTL38 during surgery.
4.1 Primary: To confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. 4.2 Secondary: To estimate the proportion of folate positive ovarian cancer patients in whom all lesions, without regard to evaluable lesion status, detected by fluorescent light only are histologically negative, the patient level False Positive Rate (FPRp). To estimate the Sensitivity and False Positive Rate for OTL38 in combination with fluorescent light with respect to the detection of FR+ ovarian cancer lesions confirmed by central pathology. To assess the safety of using OTL38 and Visionsense VS3 Imaging System for intraoperative imaging with OTL38. 4.3 Exploratory: To estimate the lesion inoperability rate for all lesions identified by fluorescent light only. To describe the diagnostic characteristics of OTL38 in combination with fluorescent light for lesions of various histological and pathological cell types. To assess CA-125 levels before and after surgery. To estimate the plasma pharmacokinetics (PK) of OTL38 in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.