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OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

NCT02872701 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-24

Study results available
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Summary

This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission tomography imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.

Conditions

Interventions

DRUG

OTL38 for Injection

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

DEVICE

Near infrared camera imaging system

Near infrared camera imaging system

PROCEDURE

Endoscopic or Thoracic Surgery

Endoscopic or Thoracic Surgery

Sponsors & Collaborators

  • Medelis Inc.

    collaborator INDUSTRY

  • On Target Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Sunil Singhal, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2018-10-31
Completion
2018-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02872701 on ClinicalTrials.gov