CompletedPhase 3NCT04241315

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other 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.

Checked against the public recordLast updated Mar 23, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations12
SponsorOn Target Laboratories, LLC
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 3
Sponsor
On Target Laboratories, LLC
Interventions being studied
Drug: OTL38 for Injection; Device: Near infrared camera imaging system
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Male and Female subjects 18 years of age and older 2. Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging 3. Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection 4. Female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion 5. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments Exclusion Criteria: 1. Previous exposure to OTL38 2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 3. History of anaphylactic reactions to folate, including synthetic folic acid (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation. 4. History of allergy to any of the components of OTL38, including folic acid 5. A positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential 6. Clinically significant abnormalities on electrocardiogram (ECG) at screening. 7. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule 8. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2 9. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>2x ULN for total bilirubin except in subjects with Gilbert's syndrome. 10. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug 11. Known sensitivity to fluorescent light

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • StamfordStamford, Connecticut
  • University of IowaIowa City, Iowa
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • University of MichiganAnn Arbor, Michigan
  • Mayo ClinicRochester, Minnesota
  • Cleveland ClinicCleveland, Ohio
  • University of PennsylvaniaPhiladelphia, Pennsylvania
  • Allegheny General HospitalPittsburgh, Pennsylvania
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
  • MD Anderson Cancer CenterHouston, Texas
  • University of VirginiaCharlottesville, Virginia
  • Swedish HospitalSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 23, 2023. Always confirm current availability with the study team.

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