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CompletedNCT02872701Updated Mar 24, 2023Results posted

OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

A Phase 2 interventional study of OTL38 for Injection and Near infrared camera imaging system in Lung Neoplasms and Lung Cancer, sponsored by On Target Laboratories, LLC. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by On Target Laboratories, LLC · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Neoplasms
  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

On Target Laboratories, LLC is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Patients Receiving OTL38

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

    Drug: OTL38 for Injection · Device: Near infrared camera imaging system · Procedure: Endoscopic or Thoracic Surgery

Interventions

  • DrugOTL38 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

    Also known as: OTL38

  • DeviceNear infrared camera imaging system

    Near infrared camera imaging system

  • ProcedureEndoscopic or Thoracic Surgery

    Endoscopic or Thoracic Surgery

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 day

  2. 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)

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. Synchronous Lesion Identification

    Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

07

Results

Posted Mar 24, 2023

Participant flow

Participant flow — Overall Study
MilestonePatients Receiving OTL38
Started100
Completed97
Not completed3

Outcome measures

PrimarySensitivity 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)

Time frame:
1 day
Reported as:
Number · proportion of lesions
Sensitivity or True Positive Rate (TPR)
proportion of lesionsPatients Receiving OTL38
Sensitivity or True Positive Rate (TPR)0.854 (0.74 to 0.92)
PrimaryFalse 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)

Time frame:
1 day
Reported as:
Number · proportion of lesions
False Positive Rate (FPR)
proportion of lesionsPatients Receiving OTL38
False Positive Rate (FPR)0.138 (0.08 to 0.23)
SecondaryProportion 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

Time frame:
1 day
Reported as:
Number · proportion of participants
Proportion of Patients With at Least 1 Clinically Significant Event (CSE)
proportion of participantsPatients Receiving OTL38
Proportion of Patients With at Least 1 Clinically Significant Event (CSE)0.293 (0.194 to 0.410)
SecondaryPositive 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

Time frame:
1 day
Reported as:
Count of participants · Participants
Positive Margin Identification
ParticipantsPatients Receiving OTL38
Positive Margin Identification8
SecondarySynchronous Lesion Identification

Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR

Time frame:
1 day
Reported as:
Count of participants · Participants
Synchronous Lesion Identification
ParticipantsPatients Receiving OTL38
Synchronous Lesion Identification7
SecondaryPulmonary 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.

Time frame:
1 day
Reported as:
Number · number of pulmonary nodules
Pulmonary Nodule Identification
number of pulmonary nodulesPatients Receiving OTL38
Pulmonary Nodule Identification10

Adverse events

Collected over AEs were collected through Day 28 (+/- 4 days) from OTL38 administration. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Patients Receiving OTL380/100 (0%)14/100 (14%)94/100 (94%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventPatients Receiving OTL38
HaemothoraxRespiratory, thoracic and mediastinal disorders2/100
Pleural effusionRespiratory, thoracic and mediastinal disorders2/100
PneumothoraxRespiratory, thoracic and mediastinal disorders2/100
PneumoniaInfections and infestations2/100
ChylothoraxRespiratory, thoracic and mediastinal disorders1/100
Lung disorderRespiratory, thoracic and mediastinal disorders1/100
Pulmonary embolismRespiratory, thoracic and mediastinal disorders1/100
Respiratory failureRespiratory, thoracic and mediastinal disorders1/100
Hip fractureInjury, poisoning and procedural complications1/100
Post procedural haemorrhageInjury, poisoning and procedural complications1/100
Most frequent other events
Showing 10 of 27
Most frequent other events
EventPatients Receiving OTL38
Procedural painInjury, poisoning and procedural complications50/100
NauseaGastrointestinal disorders33/100
CoughRespiratory, thoracic and mediastinal disorders29/100
Incision site painInjury, poisoning and procedural complications20/100
DyspnoeaRespiratory, thoracic and mediastinal disorders17/100
PneumothoraxRespiratory, thoracic and mediastinal disorders17/100
VomitingGastrointestinal disorders17/100
Pleural effusionRespiratory, thoracic and mediastinal disorders13/100
Chest painGeneral disorders12/100
HypertensionVascular disorders11/100

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Patients Receiving OTL38
<=18 years0
Between 18 and 65 years28
>=65 years72
Age, Continuous
Age, Continuous(years)Patients Receiving OTL38
Mean67.4 ± 9.35
Sex: Female, Male
Sex: Female, Male(Participants)Patients Receiving OTL38
Female68
Male32
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Patients Receiving OTL38
Hispanic or Latino1
Not Hispanic or Latino98
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Patients Receiving OTL38
American Indian or Alaska Native1
Asian7
Native Hawaiian or Other Pacific Islander0
Black or African American6
White86
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Patients Receiving OTL38
Netherlands10
United States90
08

Study locations

6 sites
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15232, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Leiden University Medical Center
    Leiden, 2333 ZA, Netherlands
09

References and documents

Study documents

  • Study protocol · Jun 14, 2018
  • Statistical analysis plan · Apr 14, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02872701
Lead sponsor
On Target Laboratories, LLC
Collaborators
Medelis Inc.
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
May 4, 2017
Primary completion
Oct 31, 2018
Completion
Nov 30, 2018
Results posted
Mar 24, 2023
Last update
Mar 24, 2023

Study contacts

Sunil Singhal, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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