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

Patients With Suspected Malignancies of the Pituitary Gland Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adenoma
• Patients With Suspected Malignancies of the Pituitary Gland
• Pituitary Diseases
• Pituitary Neoplasms

• NCT number: NCT02769533
• Study type: Interventional
• Source: Abramson Cancer Center of the University of Pennsylvania
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Completion date: August 3, 2018