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Elucidate: ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

Sponsor
On Target Laboratories, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04241315
Collaborator
Clinipace Worldwide (Industry)
140
Enrollment
12
Locations
2
Arms
19.2
Actual Duration (Months)
11.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: OTL38 for Injection
  • Device: Near infrared camera imaging system
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
140 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
Actual Study Start Date :
Mar 26, 2020
Actual Primary Completion Date :
Oct 7, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

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
Other Names:
  • CYTALUX™ (pafolacianine) injection

    • Device: Near infrared camera imaging system
    Near infrared camera imaging system
    Other: 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
    Other Names:
  • CYTALUX™ (pafolacianine) injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stamford Stamford Connecticut United States 06904
    2 University of Iowa Iowa City Iowa United States 55242
    3 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    4 University of Michigan Ann Arbor Michigan United States 48109
    5 Mayo Clinic Rochester Minnesota United States 55905
    6 Cleveland Clinic Cleveland Ohio United States 44195
    7 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    8 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    9 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    10 MD Anderson Cancer Center Houston Texas United States 77030
    11 University of Virginia Charlottesville Virginia United States 22908
    12 Swedish Hospital Seattle Washington United States 98109

    Sponsors and Collaborators

    • On Target Laboratories, LLC
    • Clinipace Worldwide

    Investigators

    • Principal Investigator: Sunil Singhal, MD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    On Target Laboratories, LLC
    ClinicalTrials.gov Identifier:
    NCT04241315
    Other Study ID Numbers:
    • OTL-2019-OTL38-007
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Lung Neoplasms

    Study Results

    No Results Posted as of Jun 1, 2022