Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)

Recruiting Phase 3 Interventional Study
5-aminolevulinic Acid Fluorescence-guided Resection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
144 (estimated)
Sponsor
Lee's Pharmaceutical Limited · Industry
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About This Trial

This is a randomized, open, parallel-group, multicenter clinical trial evaluating 5-aminolevulinic acid (5-ALA HCl) oral solution with powdered fluorescent microscopic tumor resection versus white light microscopic tumor resection in patients with malignant gliomas (WHO grade 3/4).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Males or females 18-70 years of age, inclusive; * Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging; * have a Karnofsky Performance Status (KPS) ≥ 60; * Ability to take oral medications; * Laboratory tests meeting the following criteria within…
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