Randall LM, Wenham R, Low P, et al. - In this prospective phase 2 study, researchers evaluated OTL38, a folate-indole-cyanine green-like conjugate to folate receptor alpha, for its safety and effectiveness (sensitivity and positive predictive value [PPV]) for intraoperative imaging during epithelial ovarian cancer surgery. For safety, they analyzed 44 patients; for effectiveness, evaluation of 225 lesions from 29 patients (the modified intent to treat population) was done. To visualize target lesions that were assessed by two blinded pathologists, they used near-infrared (NIR) imaging. Sensitivity and PPV of 85.93% and 88.14%, respectively, were identified when they assumed no correlation of interlesional results within a patient. Sensitivity and PPV were estimated at 97.97% and at 94.93%, respectively, when controlling for actual correlation of detection among multiple lesions within a single patient (a random impact). Irrespective of folate expression level, findings revealed the safety as well as the effectiveness of OTL38-NIR. This investigation led to FDA support of a phase 3 study.