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5-aminolevulinic Acid

Tundra lists 1 5-aminolevulinic Acid clinical trial. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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RECRUITING

NCT06160492

5-Aminolevulinic Acid for Photodynamic Diagnosis of Malignant Glioma

This phase III, multicenter, open-label, single-arm study will evaluate the ability of 5-aminolevulinic acid hydrochloride (5-ALA HCl) powder for oral solution to visualize malignant tissue during surgery, and its safety, in adults with suspected or confirmed malignant high-grade glioma (WHO grade 3 or 4). Participants will receive oral 5-ALA HCl before surgery. The primary assessments will determine the proportion of biopsy specimens containing tumor cells in strongly and weakly fluorescent regions, evaluated separately using central histopathology. Secondary assessments will include postoperative residual tumor on MRI, participant-level positive predictive values, histopathological findings in nonfluorescent regions, and safety.

Gender: All

Ages: 18 Years - 75 Years

Updated: 2026-10-27

2 states

5-aminolevulinic Acid

Fluorescence-guided Resection

High-Grade Glioma (WHO III-IV)