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.
The Phase 3 study is 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
140
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
Infrared imaging used to excite OTL38 for fluorescence
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
The Mayo Clinic - Phoenix
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Efficacy Patient Level
Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)
Time frame: 30 days
Patient False Positive Rate
False Positive Rate at the patient level (FPRp) will be a major secondary efficacy endpoint and is defined as the percentage of women who underwent both normal light and fluorescent light (Intent-to-Image Set)
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of CA at Irvine Chao Cancer Center
Orange, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Karmanos Cancer Institutes
Detroit, Michigan, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Kettering Medical Center
Kettering, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 1 more locations