Intraoperative Imaging of Pituitary Adenomas by OTL

Stopped early · Phase 1

Conditions studied: Neoplasms, Pituitary Neoplasms

In brief

The primary end-point of the study is to determine the specificity and sensitivity of OTL38 in identifying pituitary adenomas when excited by an imaging probe. The investigators intend to enroll 50 patients in this study. The study is focusing on patients presenting with suspected pituitary adenomas who are considered to be good surgical candidates.

Key facts

Study ID

NCT02629549

Run by

University of Pennsylvania

People needed

33

Starts

2015-10-01

Expected to finish

2018-08-03

Last updated by the study team

2019-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (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

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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