Intraoperative Imaging of Pituitary Adenomas by OTL

• Status: Terminated
• Trial end date: 2018-08-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania; University of Pennsylvania
• Treatments: Diphenhydramine

Criteria

Inclusion Criteria:

1. Adult patients over 18 years of age

2. Patients presenting with a pituitary nodule presumed to be resectable on pre-operative assessment

3. Good operative candidate

4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery

2. Patients with a history of anaphylactic reactions to OTL38

3. Patients with a known allergy to Benadryl

4. Previous exposure to OTL38