OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 24, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- On Target Laboratories, LLC
- Interventions being studied
- Drug: OTL38 for Injection; Device: Near infrared camera imaging system; Procedure: Endoscopic or Thoracic Surgery
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Male and Female patients 18 years of age and older 2. Confirmed diagnosis of adenocarcinoma lung cancer OR, 3. Have a primary diagnosis, or at high clinical suspicion, of lung nodule(s) warranting surgery based on CT and/or PET imaging 4. Who are scheduled to undergo endoscopic or thoracic surgery surgery 5. A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential 6. Female patients 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 7. 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
1. Previous exposure to OTL38 2. Known Folate Receptor-negative lung nodules 3. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient 4. History of anaphylactic reactions or severe allergies 5. History of allergy to any of the components of OTL38, including folic acid 6. Pregnancy, or positive pregnancy test 7. Clinically significant abnormalities on electrocardiogram (ECG) at screening. 8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 9. Impaired renal function defined as epidermal growth factor receptor (eGFR) \< 50 mL/min/1.73m2 10. 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 total bilirubin. 11. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery 12. 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.
U.S. locations
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Cleveland ClinicCleveland, Ohio
- University of PennsylvaniaPhiladelphia, Pennsylvania
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- MD Anderson Cancer CenterHouston, Texas
- Leiden University Medical CenterLeiden
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 24, 2023. Always confirm current availability with the study team.