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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

ALM-488

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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