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A Phase 1, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Pituitary Adenoma (NCT02769533)

This study is focusing on patients presenting with suspected malignancies of the pituitary gland who are considered to be good surgical candidates.The primary end-point of the study is to determine the sensitivity of OTL38 uptake and expression in identifying those nodules when excited by an imaging probe.There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, two to three hours, prior to surgery.
  • Drug: OTL0038
    • Drug: Benadryl
      • Device: intraoperative imaging
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        Inclusion Criteria:
        • Adult patients over 18 years of age
        • Patients presenting with a pituitary nodule presumed to be resectable on pre-operative assessment
        • Good operative candidate
        • Subject capable of giving informed consent and participating in the process of consent.
        Exclusion Criteria:
        • Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
        • Patients with a history of anaphylactic reactions to OTL38
        • Patients with a known allergy to Benadryl
        • Previous exposure to OTL38

        1 locations

        United States (1)
        • Abramson Cancer Center of the University of Pennsylvania
          recruiting
          Philadelphia, Pennsylvania, United States, 19104
        Status:
        recruiting
        Type:
        Interventional
        Phase:
        Start:
        31 August, 2015
        Updated:
        27 July, 2017
        Participants:
        50
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