ELUCIDATE: Enabling LUng Cancer IDentification Using folATE Receptor Targeting

STATUS

Recruiting
participants needed

130
sponsor

On Target Laboratories, LLC

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Updated on 19 February 2024

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cancer

folic acid

lung cancer

pulmonary resection

thoracic surgery

thoracoscopy

infrared imaging

wedge resection

wedge excision

Summary

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.

Details

Condition	Pulmonary Disease, Lung Neoplasm
Age	18-100 years
Treatment	OTL38 for Injection, Near infrared camera imaging system
Clinical Study Identifier	NCT04241315
Sponsor	On Target Laboratories, LLC
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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

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ELUCIDATE: Enabling LUng Cancer IDentification Using folATE Receptor Targeting