OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
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|ClinicalTrials.gov Identifier: NCT02872701|
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Lung Cancer||Drug: OTL38 for Injection Device: Near infrared camera imaging system||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 4, 2017|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||November 30, 2018|
Experimental: Patients Receiving OTL38
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
Drug: OTL38 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
Other Name: OTL38
Device: Near infrared camera imaging system
Near infrared camera imaging system
- Clinically Significant Events (CSE) [ Time Frame: 1 day ]The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.
- Pulmonary Nodule Identification [ Time Frame: 1 day ]Number of pulmonary nodules identified with OTL-38 and Near Infrared Imaging (NIR) that could not otherwise be identified by white light and palpation.
- Synchronous Lesion Identification [ Time Frame: 1 day ]Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR
- Positive Margin Identification [ Time Frame: 1 day ]Number of patients where at least one positive margin is identified with only OTL-38 and NIR.
- Detection rates of adenocarcinoma between OTL38 fluorescence at time of surgery vs. frozen section assessment as determined by final pathology report. [ Time Frame: 1 day ]
- Comparison of fluorescing lesions vs. proportion of lesions expressing Folate-Receptor alpha (FRα+) and Folate Receptor beta (FRβ+) as determined by immunohistochemical analysis [ Time Frame: 1 day ]
- Incidence rates of all adverse events (AEs), treatment-emergent AEs (TEAEs), adverse device events (ADEs), and serious adverse events (SAEs.) [ Time Frame: Through study completion, about 4 weeks. ]
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to OTL38. [ Time Frame: Through study completion, about 4 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872701
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Leiden University Medical Center|
|Leiden, Netherlands, 2333 ZA|
|Principal Investigator:||Sunil Singhal, MD||University of Pennsylvania|