NCT02872701

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2017

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

May 4, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 24, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

August 5, 2016

Results QC Date

January 13, 2023

Last Update Submit

March 23, 2023

Conditions

Lung NeoplasmsLung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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)

    1 day

  • 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)

    1 day

Secondary Outcomes (4)

  • Proportion of Patients With at Least 1 Clinically Significant Event (CSE)

    1 day

  • Positive Margin Identification

    1 day

  • Synchronous Lesion Identification

    1 day

  • Pulmonary Nodule Identification

    1 day

Study Arms (1)

Patients Receiving OTL38

EXPERIMENTAL

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

Drug: OTL38 for InjectionDevice: Near infrared camera imaging systemProcedure: Endoscopic or Thoracic Surgery

Interventions

OTL38 for InjectionDRUG

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

Also known as: OTL38
Patients Receiving OTL38
Near infrared camera imaging systemDEVICE

Near infrared camera imaging system

Patients Receiving OTL38
Endoscopic or Thoracic SurgeryPROCEDURE

Endoscopic or Thoracic Surgery

Patients Receiving OTL38

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

PafolacianineInjectionsEndoscopyThoracic Surgical Procedures

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Tim Biro
Organization
On Target Laboratories
tbiro@ontargetlabs.com
216-533-3082

Study Officials

  • Sunil Singhal, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 19, 2016

Study Start

May 4, 2017

Primary Completion

October 31, 2018

Study Completion

November 30, 2018

Last Updated

March 24, 2023

Results First Posted

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)US(5)