Clinical trial NCT02872701: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Lung Cancer
Lead sponsor: On Target Laboratories, LLC
Sponsor class: INDUSTRY
Collaborators: name: Medelis Inc.
First posted: 2016-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity or True Positive Rate (TPR)
timeFrame: 1 day
measure: False Positive Rate (FPR)
timeFrame: 1 day
Secondary outcomes:
measure: Proportion of Patients With at Least 1 Clinically Significant Event (CSE)
timeFrame: 1 day
measure: Positive Margin Identification
timeFrame: 1 day
measure: Synchronous Lesion Identification
timeFrame: 1 day
measure: Pulmonary Nodule Identification
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: University of Pennsylvania
name: Sunil Singhal, MD
role: PRINCIPAL_INVESTIGATOR
References: