A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Neoplasms
- Imaging
- Nerve Injury
- Parotid Neoplasm
- Surgery
- Thyroid Neoplasms
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: This is a Phase 1/Phase 2 study in patients undergoing Head & Neck Surgery.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04420689
- Collaborators
- Not Provided
- Investigators
- Not Provided
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