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

Primary Purpose

Lung Neoplasms, Lung Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OTL38 for Injection
Near infrared camera imaging system
Sponsored by
On Target Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Intraoperative Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stamford
  • University of Iowa
  • Beth Israel Deaconess Medical Center
  • University of Michigan
  • Mayo Clinic
  • Cleveland Clinic
  • University of Pennsylvania
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • MD Anderson Cancer Center
  • University of Virginia
  • Swedish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Near-Infrared Imaging group

No Imaging Group

Arm Description

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

Outcomes

Primary Outcome Measures

Clinically Significant Events (CSE)
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.
Localization of Primary Nodule
Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation
Identification of Cancerous Synchronous Lesions
The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation
Positive Resection Margins
The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line

Secondary Outcome Measures

Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects
Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.
False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects
False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions

Full Information

First Posted
January 22, 2020
Last Updated
February 23, 2023
Sponsor
On Target Laboratories, LLC
Collaborators
Clinipace Worldwide
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1. Study Identification

Unique Protocol Identification Number
NCT04241315
Brief Title
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
Acronym
Elucidate
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2020 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
On Target Laboratories, LLC
Collaborators
Clinipace Worldwide

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Lung Cancer
Keywords
Intraoperative Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Near-Infrared Imaging group
Arm Type
Experimental
Arm Description
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
Arm Title
No Imaging Group
Arm Type
Other
Arm Description
All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.
Intervention Type
Drug
Intervention Name(s)
OTL38 for Injection
Other Intervention Name(s)
CYTALUX™ (pafolacianine) injection
Intervention Description
Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Intervention Type
Device
Intervention Name(s)
Near infrared camera imaging system
Intervention Description
Near infrared camera imaging system
Primary Outcome Measure Information:
Title
Clinically Significant Events (CSE)
Description
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.
Time Frame
1 day
Title
Localization of Primary Nodule
Description
Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation
Time Frame
1 day
Title
Identification of Cancerous Synchronous Lesions
Description
The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation
Time Frame
1 day
Title
Positive Resection Margins
Description
The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects
Description
Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.
Time Frame
1 day
Title
False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects
Description
False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female subjects 18 years of age and older Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection 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 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: Previous exposure to OTL38 Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 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. History of allergy to any of the components of OTL38, including folic acid 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 Clinically significant abnormalities on electrocardiogram (ECG) at screening. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule Impaired renal function defined as eGFR< 50 mL/min/1.73m2 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. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug Known sensitivity to fluorescent light
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Singhal, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stamford
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
55242
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

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