Lung NeoplasmsPhase 2NCT02872701
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
A Phase 2 study testing OTL38 for Injection, Near infrared camera imaging system and Endoscopic or Thoracic Surgery in people with Lung Neoplasms and Lung Cancer, run by On Target Laboratories, LLC at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Neoplasms, Lung Cancer
- What is being tested?
- OTL38 for Injection, Near infrared camera imaging system and Endoscopic or Thoracic Surgery
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 4 May 2017to 30 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44195
MD Anderson Cancer Center
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
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
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.
- Conditions
- Lung Neoplasms, Lung Cancer
- Being tested
- OTL38 for Injection, Near infrared camera imaging system, Endoscopic or Thoracic Surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTL38 for InjectionDrug
Also called OTL38
Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Near infrared camera imaging systemDevice
Near infrared camera imaging system
Endoscopic or Thoracic SurgeryProcedure or surgery
Endoscopic or Thoracic Surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving OTL38 | Experimental | All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. Receives: Drug: OTL38 for Injection; Device: Near infrared camera imaging system; Procedure: Endoscopic or Thoracic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 1 day
Secondary outcomes (4)
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
Measured: 1 day
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
Measured: 1 day
Synchronous Lesion Identification
Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start4 May 2017
- Primary completion31 Oct 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- On Target Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Responsible party
- Sponsor
- Investigators
- Sunil Singhal, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872701
- Sponsor's protocol ID
- OTL-2016-OTL38-005
- Status last verified
- Mar 2023
- First submitted
- 5 Aug 2016
- Last updated
- 24 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02872701
- Acronym / sponsor ID
- OTL-2016-OTL38-005
- Conditions
- Lung Neoplasms, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- On Target Laboratories, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Study start
- 4 May 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 24 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving OTL38 | Experimental | Drug: OTL38 for Injection, Device: Near infrared camera imaging system, Procedure: Endoscopic or Thoracic SurgeryAll patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTL38 for InjectionAlso: OTL38Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL | Drug | Patients Receiving OTL38 |
| Near infrared camera imaging systemNear infrared camera imaging system | Device | Patients Receiving OTL38 |
| Endoscopic or Thoracic SurgeryEndoscopic or Thoracic Surgery | Procedure or surgery | Patients Receiving OTL38 |
Primary outcome
Sensitivity or True Positive Rate (TPR)
Time frame: 1 day
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)
Time frame: 1 day
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)
4 secondary outcomes
Proportion of Patients With at Least 1 Clinically Significant Event (CSE)
Time frame: 1 day
Positive Margin Identification
Time frame: 1 day
Synchronous Lesion Identification
Time frame: 1 day
Pulmonary Nodule Identification
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Singhal, MD principal investigator
University of Pennsylvania
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OTL38 for Injection, Near infrared camera imaging system and Endoscopic or Thoracic Surgery in people with Lung Neoplasms and Lung Cancer, run by On Target Laboratories, LLC at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity or True Positive Rate (TPR) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.