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:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/8/2016
Start Date:September 2015
Contact:Sunil Singhal, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
Abramson Cancer Center of the University of Pennsylvania
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Sunil Singhal, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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