Neoplasms

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Thyroid Diseases

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Parotid Neoplasms

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Endocrine System Diseases

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Parotid Diseases

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This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.

This arm of the study will include Dose Timing cohorts of ALM-488.

ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

ALM-488

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head \& neck surgery.

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.

This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.

A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Concentration of ALM-488 in blood at varying times following ALM-488 administration.

To determine the recommended dose of ALM-488.

To evaluate the effect of timing of administration of ALM-488.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery	NCT04420689	Parotid Neoplas... Thyroid Neoplas... Head and Neck N... Surgery Nerve Injury Imaging	ALM-488	18 Years -	Alume Biosciences, Inc.
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery	NCT04420689	Parotid Neoplas... Thyroid Neoplas... Head and Neck N... Surgery Nerve Injury Imaging	ALM-488	18 Years -	Alume Biosciences, Inc.

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