Fluorescent Imaging Ligand OTL38 in Diagnosing Cancer in Patients with Resectable Solid Tumors

Status: Complete

Description

This early phase I trial studies how well fluorescent imaging ligand OTL38 (OTL38) works in diagnosing cancer in patients with solid tumors that can be removed by surgery. OTL38 is made by linking folate (a vitamin) to a fluorescent agent, called indole-cyanine. OTL38 and intraoperative imaging during surgery may help doctors to identify solid tumor mass and / or diseased tissue like noncancerous masses.

Eligibility Criteria

Inclusion Criteria

  • Subjects presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable or are at risk for recurrence
  • Good operative candidate as determined by the treating physician and/or multidisciplinary team
  • 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 unless (1) they are menopausal defined as not having a menstrual cycle for at least 12 consecutive months or (2) they have had a hysterectomy
  • Subjects with a history of anaphylactic reactions to OTL38
  • Subjects with a known allergy to Benadryl
  • Previous exposure to OTL38 components
  • Vulnerable subject populations: * Alcohol or substance abuse * Children and neonates * Unable to participate in the consent process * Homeless

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To collect prospective data on cancer subjects who undergo surgery and intraoperative imaging.

OUTLINE:

Patients receive fluorescent imaging ligand OTL38 intravenously (IV) over 40-60 minutes and then undergo surgery for removal of their tumor with intraoperative imaging.

After completion of study, patients are followed up for 2-4 weeks.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Sunil Singhal

Trial IDs

Primary ID UPCC 05916
Secondary IDs NCI-2019-00993
Clinicaltrials.gov ID NCT02852252