OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Condition: Lung Neoplasms; Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: OTL38 for Injection; Near infrared camera imaging system; Endoscopic or Thoracic Surgery
Intervention description: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL; Near infrared camera imaging system; Endoscopic or Thoracic Surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung
      cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission
      tomography imaging based on standard of care. This study aims to assess the efficacy of OTL38
      and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating
      theater, and to assess the safety and tolerability of single intravenous doses of OTL38.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and Female patients 18 years of age and older

          2. Confirmed diagnosis of adenocarcinoma lung cancer OR,

          3. Have a primary diagnosis, or at high clinical suspicion, of lung nodule(s) warranting
             surgery based on CT and/or PET imaging

          4. Who are scheduled to undergo endoscopic or thoracic surgery surgery

          5. 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

          6. 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

          7. Ability to understand the requirements of the study, provide written informed consent
             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:

          1. Previous exposure to OTL38

          2. Known Folate Receptor-negative lung nodules

          3. Any medical condition that in the opinion of the investigators could potentially
             jeopardize the safety of the patient

          4. History of anaphylactic reactions or severe allergies

          5. History of allergy to any of the components of OTL38, including folic acid

          6. Pregnancy, or positive pregnancy test

          7. Clinically significant abnormalities on electrocardiogram (ECG) at screening.

          8. Presence of any psychological, familial, sociological or geographical condition
             potentially hampering compliance with the study protocol and follow-up schedule

          9. Impaired renal function defined as epidermal growth factor receptor (eGFR) < 50
             mL/min/1.73m2

         10. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for
             alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline
             phosphatase (ALP), or total bilirubin.

         11. Received an investigational agent in another investigational drug or vaccine trial
             within 30 days prior to surgery

         12. Known sensitivity to fluorescent light