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

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.

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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02852252.

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 PhasePhase O

Trial Typediagnostic

Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center

Principal InvestigatorSunil Singhal

Primary IDUPCC 05916
Secondary IDsNCI-2019-00993
ClinicalTrials.gov IDNCT02852252

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

Inclusion Criteria

Exclusion Criteria

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

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

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Trial IDs

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