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Trial record 1 of 1 for:    NCT04241315
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OTL38 for Intraoperative Imaging of Folate Receptor Positive Lung Nodules (Elucidate)

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ClinicalTrials.gov Identifier: NCT04241315
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Clinipace Worldwide
Information provided by (Responsible Party):
On Target Laboratories, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Lung Cancer Drug: OTL38 for Injection Device: Near infrared camera imaging system Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Estimated Study Start Date : March 26, 2020
Estimated Primary Completion Date : April 26, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Near-Infrared Imaging group
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

Device: Near infrared camera imaging system
Near infrared camera imaging system
No Imaging Group
All patients in this arm will receive OTL38 for injection but will not receive 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


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and Female subjects 18 years of age and older
  2. Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
  3. Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
  4. 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
  5. 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. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
  3. 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.
  4. History of allergy to any of the components of OTL38, including folic acid
  5. 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
  6. Clinically significant abnormalities on electrocardiogram (ECG) at screening.
  7. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
  8. Impaired renal function defined as eGFR< 50 mL/min/1.73m2
  9. 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.
  10. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
  11. Known sensitivity to fluorescent light
Contacts and Locations
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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): NCT04241315


Contacts
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Contact: Aaron J Blouin 215-908-5866 ablouin@ontargetlabs.com

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: Research Coordinator    617-632-8386      
Principal Investigator: Sidharta Gangadharan, MD         
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Research Coordinator       BOWMANM3@ccf.org   
Principal Investigator: Sudish Murthy, M.D., Ph.D         
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Sunil Singhal, MD    215-615-5864    sunil.singhal@uphs.upenn.edu   
Principal Investigator: Sunil Singhal, MD         
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie Ward, BSN    412-647-8583    wardj@upmc.edu   
Principal Investigator: Interpal Sarkaria, MD         
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Craig DeDegraaf    713-563-9155    cedegra@mdanderson.org   
Principal Investigator: David Rice, M.B., B.Ch.         
Sponsors and Collaborators
On Target Laboratories, LLC
Clinipace Worldwide
Investigators
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Principal Investigator: Sunil Singhal, MD University of Pennsylvania
More Information
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Responsible Party: On Target Laboratories, LLC
ClinicalTrials.gov Identifier: NCT04241315    
Other Study ID Numbers: OTL-2019-OTL38-007
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by On Target Laboratories, LLC:
Intraoperative Imaging
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Folic Acid
 Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs