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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769533
• Other study ID #: UPCC 18315
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: August 3, 2018

Study information

• Verified date: February 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• OTL0038

• Benadryl

Device:
• intraoperative imaging

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		five years
Primary	Number of pituitary adenomas are detected by intraoperative imaging		five years