ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
Completed · Phase 3
Conditions studied: Lung Neoplasms, Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT04241315
- Run by
- On Target Laboratories, LLC
- People needed
- 112
- Starts
- 2020-03-26
- Expected to finish
- 2021-11-01
- Last updated by the study team
- 2023-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and Female subjects 18 years of age and older
- Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
- Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
- 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
- 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
You may not qualify if…
- Previous exposure to OTL38
- Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
- 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.
- History of allergy to any of the components of OTL38, including folic acid
- 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
- Clinically significant abnormalities on electrocardiogram (ECG) at screening.
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
- Impaired renal function defined as eGFR< 50 mL/min/1.73m2
- 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.
- Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
- Known sensitivity to fluorescent light
Where it is running
- Stamford — Stamford, Connecticut, United States
- University of Iowa — Iowa City, Iowa, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
- Swedish Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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