Spots Global Cancer Trial Database for A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery
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Trial Identification
Brief Title: A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Official Title: Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
Study ID: NCT04420689
Interventions
Study Description
Brief Summary: Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head \& neck surgery.
Detailed Description: This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head \& neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego, San Diego, California, United States
Stanford University, Stanford, California, United States
Harvard-Mass Eye & Ear, Boston, Massachusetts, United States
Contact Details
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