Intraoperative Imaging using OTL38 in Diagnosing Patients with Lung or Pleura Nodules Undergoing Surgery

Status: Active

Description

This phase II trial studies intraoperative imaging using fluorescent imaging ligand OTL38 (OTL38) in diagnosing patients with lung or pleura nodules undergoing surgery. Drugs, such as OTL38, attach to the cancer and "mark" it. During surgery, the surgeons hold a camera system over the nodule that will excite OTL38. Imaging during surgery may cause the nodule to glow, thus "marking" the cancer and making it easier for surgeons to remove.

Eligibility Criteria

Inclusion Criteria

  • Patients presenting with a lung or pleural nodule or mass 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.
  • At-risk patient populations. * Homeless patients. * Patients with drug or alcohol dependence. * Children and neonates. * Patients unable to participate in the consent process.

Locations & Contacts

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Sunil Singhal
Phone: 215-298-4998
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 (FRalpha+) lung adenocarcinomas during surgery.

OUTLINE:

Patients receive Benadryl intravenously (IV) and fluorescent imaging ligand OTL38 IV over 60 minutes 2-3 hours before surgery. Patients then undergo imaging of lung and chest cavity using the Artemis handheld camera system before and after surgical resection.

After completion of study, patients are followed up for 5 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Sunil Singhal

Trial IDs

Primary ID UPCC 04515
Secondary IDs NCI-2016-00753
Clinicaltrials.gov ID NCT02769156