Back to resultsOTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Primary Purpose
Lung Neoplasms, Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OTL38 for Injection
Near infrared camera imaging system
Endoscopic or Thoracic Surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Male and Female patients 18 years of age and older
- Confirmed diagnosis of adenocarcinoma lung cancer OR,
- Have a primary diagnosis, or at high clinical suspicion, of lung nodule(s) warranting surgery based on CT and/or PET imaging
- Who are scheduled to undergo endoscopic or thoracic surgery surgery
- 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
- 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:
- Previous exposure to OTL38
- Known Folate Receptor-negative lung nodules
- Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
- History of anaphylactic reactions or severe allergies
- History of allergy to any of the components of OTL38, including folic acid
- Pregnancy, or positive pregnancy test
- Clinically significant abnormalities on electrocardiogram (ECG) at screening.
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Impaired renal function defined as epidermal growth factor receptor (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 total bilirubin.
- Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
- Known sensitivity to fluorescent light
Sites / Locations
- Beth Israel Deaconess Medical Center
- Cleveland Clinic
- University of Pennsylvania
- University of Pittsburgh Medical Center
- MD Anderson Cancer Center
- Leiden University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients Receiving OTL38
Arm Description
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
Outcomes
Primary Outcome Measures
Sensitivity or True Positive Rate (TPR)
Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive tissue samples (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be FR+ and lung cancer by central pathology relative to the total number of tissue samples confirmed to be FR+ and lung cancer by central pathology.
Sensitivity = (True Positive)/(True Positive +False Negative)
False Positive Rate (FPR)
False positive rate (FPR) for OTL38 in combination with fluorescent light, for the purpose of this protocol, will be calculated as 1 - the Positive Predictive Value (PPV) and is defined as the proportion of fluorescent light positive tissue samples removed (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be non-cancerous, or if cancerous, not FR+ and lung cancer, by central pathology relative to the total number of tissue samples removed with fluorescent light imaging. False Positive Rate = (False Positives) / (True Positives + False Positives)
Secondary Outcome Measures
Proportion of Patients With at Least 1 Clinically Significant Event (CSE)
Proportion of patients with at least 1 Clinically Significant Event (CSE as a result of utilizing OLT-38 and Near Infrared Imaging
Positive Margin Identification
Number of patients where at least one positive margin (fluorescent cancerous cells within 5 mm of the staple line) is identified with only OTL-38 and NIR
Synchronous Lesion Identification
Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR
Pulmonary Nodule Identification
Number of pulmonary nodules identified with OTL-38 and Near Infrared Imaging (NIR) that could not otherwise be identified by white light and palpation.
Full Information
NCT ID
NCT02872701
First Posted
August 5, 2016
Last Updated
March 23, 2023
Sponsor
On Target Laboratories, LLC
Collaborators
Medelis Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02872701
Brief Title
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
On Target Laboratories, LLC
Collaborators
Medelis Inc.
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients Receiving OTL38
Arm Type
Experimental
Arm Description
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
Intervention Type
Drug
Intervention Name(s)
OTL38 for Injection
Other Intervention Name(s)
OTL38
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
Intervention Type
Procedure
Intervention Name(s)
Endoscopic or Thoracic Surgery
Intervention Description
Endoscopic or Thoracic Surgery
Primary Outcome Measure Information:
Title
Sensitivity or True Positive Rate (TPR)
Description
Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive tissue samples (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be FR+ and lung cancer by central pathology relative to the total number of tissue samples confirmed to be FR+ and lung cancer by central pathology.
Sensitivity = (True Positive)/(True Positive +False Negative)
Time Frame
1 day
Title
False Positive Rate (FPR)
Description
False positive rate (FPR) for OTL38 in combination with fluorescent light, for the purpose of this protocol, will be calculated as 1 - the Positive Predictive Value (PPV) and is defined as the proportion of fluorescent light positive tissue samples removed (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be non-cancerous, or if cancerous, not FR+ and lung cancer, by central pathology relative to the total number of tissue samples removed with fluorescent light imaging. False Positive Rate = (False Positives) / (True Positives + False Positives)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Proportion of Patients With at Least 1 Clinically Significant Event (CSE)
Description
Proportion of patients with at least 1 Clinically Significant Event (CSE as a result of utilizing OLT-38 and Near Infrared Imaging
Time Frame
1 day
Title
Positive Margin Identification
Description
Number of patients where at least one positive margin (fluorescent cancerous cells within 5 mm of the staple line) is identified with only OTL-38 and NIR
Time Frame
1 day
Title
Synchronous Lesion Identification
Description
Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR
Time Frame
1 day
Title
Pulmonary Nodule Identification
Description
Number of pulmonary nodules identified with OTL-38 and Near Infrared Imaging (NIR) that could not otherwise be identified by white light and palpation.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and Female patients 18 years of age and older
Confirmed diagnosis of adenocarcinoma lung cancer OR,
Have a primary diagnosis, or at high clinical suspicion, of lung nodule(s) warranting surgery based on CT and/or PET imaging
Who are scheduled to undergo endoscopic or thoracic surgery surgery
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
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:
Previous exposure to OTL38
Known Folate Receptor-negative lung nodules
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
History of anaphylactic reactions or severe allergies
History of allergy to any of the components of OTL38, including folic acid
Pregnancy, or positive pregnancy test
Clinically significant abnormalities on electrocardiogram (ECG) at screening.
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Impaired renal function defined as epidermal growth factor receptor (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 total bilirubin.
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
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
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
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
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
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