蛍光誘導下悪性神経膠腫切除術におけるNPC-07の研究

基本情報

NCT ID

NCT01167322

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

45

治験依頼者名

Nobelpharma

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)