ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
Condition: Lung Neoplasms; Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: OTL38 for Injection; Near infrared camera imaging system
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
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intraoperative Imaging

Summary:

      This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung
      cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other
      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 subjects 18 years of age and older

          2. Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung
             warranting surgery based on CT/PET or other imaging

          3. Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed
             by anatomic lung resection

          4. Female subjects 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

          5. 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. Any medical condition that in the opinion of the investigators could potentially
             jeopardize the safety of the subject

          3. History of anaphylactic reactions to folate, including synthetic folic acid
             (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near
             infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will
             require evaluation.

          4. History of allergy to any of the components of OTL38, including folic acid

          5. A positive serum pregnancy test at Screening or a positive urine pregnancy test on the
             day of surgery or day of admission for female subjects of childbearing potential

          6. Clinically significant abnormalities on electrocardiogram (ECG) at screening.

          7. Presence of any psychological, familial, sociological condition or geographical
             challenges potentially hampering compliance with the study protocol and follow-up
             schedule

          8. Impaired renal function defined as eGFR< 50 mL/min/1.73m2

          9. 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 >2x ULN for total bilirubin except in subjects with Gilbert's
             syndrome.

         10. Received an investigational agent in another investigational drug or vaccine trial
             within 30 days prior to the administration of study drug

         11. Known sensitivity to fluorescent light