Malignant Glioma Clinical Trial
Official title:
Clinical Study to Assess the Positive Predictive Value of NPC-07 Induced Tissue Fluorescence in Patients With Malignant Glioma (WHO Grades III/IV)
The aim of the present Phase III study is to assess the positive predictive value of NPC-07
(5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and
pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight,
3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent
malignant glioma (WHO grades III/IV).
Positive predictive value will be confirmed by percentage of patients showing positive tumor
cell identification in all biopsies taken from areas of strong and weak fluorescence. This
study will be divided into two stages. After reviewing of the result of safety and
pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring
committee, more subjects will receive NPC-07 in Step II.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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