OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: OTL38; near infrared camera imaging system; laparotomy
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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