Spots Global Cancer Trial Database for ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
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Trial Identification
Brief Title: ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
Official Title: A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Study ID: NCT04241315
Study Description
Brief Summary: This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other 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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stamford, Stamford, Connecticut, United States
University of Iowa, Iowa City, Iowa, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Cleveland Clinic, Cleveland, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Swedish Hospital, Seattle, Washington, United States
Contact Details
Name: Sunil Singhal, MD
Affiliation: University of Pennsylvania
Role: PRINCIPAL_INVESTIGATOR
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