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drugset / Trial / NCT05101798

The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial

NCT05101798 ↗

Phase 2 Terminated 7 enrolled Icahn School of Medicine at Mount Sinai NX Development Corp · collab
NaSingle-groupOpen-labelDiagnostic

Summary

This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic acid (5-ALA) is a safe and effective FDA-approved agent successfully used by neurosurgeons for FGS of different brain tumors is given to the patients preoperatively. Using specific wavelengths of light as well as specialized magnified lenses the surgeons use this technique to assist in tumor resection.

Timeline

Start
2021-09-14
Primary completion
2022-12-25
Completion
2022-12-25

Outcome

Outcome not reported

Stopped: “NX Development Corporation closed the trial”

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 20 mg/kg Oral

Indications

skull base neoplasm