This study is being done to: * test the safety of OTL38 * see if OTL38 helps light up the cancer when viewed with the special camera system * test the safety of the special camera system for use along with OTL38 during surgery
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
48
Near infrared camera imaging system
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
University of CA at Irvine Chao Cancer Center
Orange, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.
Time frame: Day of Surgery (Day 1)
Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP). 95% lower one-sided confidence interval was used.
Time frame: Day of Surgery (Day 1)
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