Clinical Trial: 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
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief Summary: 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.
Detailed Summary:
Sponsor: Abramson Cancer Center of the University of Pennsylvania
Current Primary Outcome:
- Number of Adverse Events [ Time Frame: five years ]
- Number of pituitary adenomas are detected by intraoperative imaging [ Time Frame: five years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Abramson Cancer Center of the University of Pennsylvania
Dates:
Date Received: May 10, 2016
Date Started: September 2015
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016
