OTL38 in Imaging Patients with Suspected Pituitary Adenoma Undergoing Surgery

Status: Active

Description

This phase I trial studies whether fluorescent imaging ligand OTL38 (OTL38) can identify pituitary adenomas during surgery in patients undergoing surgery for suspected pituitary adenomas. Pituitary gland adenomas are benign tumors, but can cause problems because of their size and proximity to the brain, and because of the hormones they can make. Fluorescent imaging ligand OTL38 may cause the tissue of the tumor to glow, and allow it to be seen by doctors using special cameras. This may allow the doctors to make sure the entire tumor is removed during surgery, and may allow them to find other tumors that were not previously identified.

Eligibility Criteria

Inclusion Criteria

  • 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 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

Locations & Contacts

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Sunil Singhal
Phone: 215-662-4767
Email: sunil.singhal@uphs.upenn.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the sensitivity and specificity of OTL38 in detecting folate receptor-alpha positive (FR alpha +) pituitary adenomas during surgery.

OUTLINE:

Patients receive fluorescent imaging ligand OTL38 intravenously (IV) over approximately 60 minutes 2-3 hours before surgery. Once the tumor is exposed, it is imaged using an intraoperative imaging device to determine if the tumor is fluorescent and if any other tumors are present. Patients then undergo standard of care surgical resection. After the tumor is removed, the area is re-imaged to ensure no additional tumors remain.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Sunil Singhal

Trial IDs

Primary ID UPCC 18315
Secondary IDs NCI-2015-01600, 822782
Clinicaltrials.gov ID NCT02769533