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Spots Global Cancer Trial Database for OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

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Trial Identification

Brief Title: 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 ID: NCT02872701

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Cleveland Clinic, Cleveland, Ohio, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center, Houston, Texas, United States

Leiden University Medical Center, Leiden, , Netherlands

Contact Details

Name: Sunil Singhal, MD

Affiliation: University of Pennsylvania

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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