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OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02872701
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Medelis Inc.
Information provided by (Responsible Party):
On Target Laboratories, LLC

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
Lung Neoplasms Lung Cancer Drug: OTL38 for Injection Device: Near infrared camera imaging system 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2, Single Dose, Open-Label, Exploratory Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Actual Study Start Date : May 4, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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 Name: OTL38

Device: Near infrared camera imaging system
Near infrared camera imaging system




Primary Outcome Measures :
  1. Clinically Significant Events (CSE) [ Time Frame: 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 :
  1. Pulmonary Nodule Identification [ Time Frame: 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.

  2. Synchronous Lesion Identification [ Time Frame: 1 day ]
    Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR

  3. Positive Margin Identification [ Time Frame: 1 day ]
    Number of patients where at least one positive margin is identified with only OTL-38 and NIR.


Other Outcome Measures:
  1. Detection rates of adenocarcinoma between OTL38 fluorescence at time of surgery vs. frozen section assessment as determined by final pathology report. [ Time Frame: 1 day ]
  2. Comparison of fluorescing lesions vs. proportion of lesions expressing Folate-Receptor alpha (FRα+) and Folate Receptor beta (FRβ+) as determined by immunohistochemical analysis [ Time Frame: 1 day ]
  3. Incidence rates of all adverse events (AEs), treatment-emergent AEs (TEAEs), adverse device events (ADEs), and serious adverse events (SAEs.) [ Time Frame: Through study completion, about 4 weeks. ]
  4. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to OTL38. [ Time Frame: Through study completion, about 4 weeks. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

Exclusion Criteria:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872701


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Sponsors and Collaborators
On Target Laboratories, LLC
Medelis Inc.
Investigators
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Principal Investigator: Sunil Singhal, MD University of Pennsylvania
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Responsible Party: On Target Laboratories, LLC
ClinicalTrials.gov Identifier: NCT02872701    
Other Study ID Numbers: OTL-2016-OTL38-005
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases