OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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 (PET) imaging based on standard of care.
Two to three hours prior to surgery, patients will be infused with OTL38. After the patient is intubated and surgical site incised, the surgeon will locate and document all nodules identifiable by white light, manual palpation, and Near-Infrared Imaging (NIR). This will be documented and recorded. Surgery will be completed per surgeon's standard of care, afterwards the area will be reviewed under standard and infrared light. All samples will be sent for pathology and immunohistochemistry (IHC) evaluation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients Receiving OTL38 All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. |
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
Other Names:
Device: Near infrared camera imaging system
Near infrared camera imaging system
Procedure: Endoscopic or Thoracic Surgery
Endoscopic or Thoracic Surgery
|
Outcome Measures
Primary Outcome Measures
- Clinically Significant Events (CSE) [1 day]
The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.
Secondary Outcome Measures
- Pulmonary Nodule Identification [1 day]
Number of pulmonary nodules identified with OTL-38 and Near Infrared Imaging (NIR) that could not otherwise be identified by white light and palpation.
- Synchronous Lesion Identification [1 day]
Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR
- Positive Margin Identification [1 day]
Number of patients where at least one positive margin is identified with only OTL-38 and NIR.
Other Outcome Measures
- Detection rates of adenocarcinoma between OTL38 fluorescence at time of surgery vs. frozen section assessment as determined by final pathology report. [1 day]
- Comparison of fluorescing lesions vs. proportion of lesions expressing Folate-Receptor alpha (FRα+) and Folate Receptor beta (FRβ+) as determined by immunohistochemical analysis [1 day]
- Incidence rates of all adverse events (AEs), treatment-emergent AEs (TEAEs), adverse device events (ADEs), and serious adverse events (SAEs.) [Through study completion, about 4 weeks.]
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to OTL38. [Through study completion, about 4 weeks.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and Female patients 18 years of age and older
-
Confirmed diagnosis of adenocarcinoma lung cancer OR,
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Have a primary diagnosis, or at high clinical suspicion, of lung nodule(s) warranting surgery based on CT and/or PET imaging
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Who are scheduled to undergo endoscopic or thoracic surgery surgery
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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
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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
-
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:
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Previous exposure to OTL38
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Known Folate Receptor-negative lung nodules
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Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
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History of anaphylactic reactions or severe allergies
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History of allergy to any of the components of OTL38, including folic acid
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Pregnancy, or positive pregnancy test
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Clinically significant abnormalities on electrocardiogram (ECG) at screening.
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Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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Impaired renal function defined as epidermal growth factor receptor (eGFR) < 50 mL/min/1.73m2
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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.
-
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
-
Known sensitivity to fluorescent light
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 2 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 3 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 4 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 5 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 6 | Leiden University Medical Center | Leiden | Netherlands | 2333 ZA |
Sponsors and Collaborators
- On Target Laboratories, LLC
- Medelis Inc.
Investigators
- Principal Investigator: Sunil Singhal, MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OTL-2016-OTL38-005