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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
45
NPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight.
International Medical Center, Saitama Medical University
Hidaka, Saitama, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Positive predictive value of tissue fluorescence
Positive predictive value of tissue fluorescence defined as the percentage of patients showing positive tumor cell identification in all 6 biopsies taken from areas of strong and weak fluorescence.
Time frame: 1 day
Quality of fluorescent tissue
Quality of fluorescent tissue by the judgement of the investigator
Time frame: 1 day
Positive predictive value of tissue fluorescence in each biopsy tissue sample
Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among all biopsies taken from areas of strong and weak fluorescence.
Time frame: 1 day
Percentage of patients without residual tumor
Percentage of patients without residual tumor in the MRI within 72 hours after surgery
Time frame: 3 days
Positive predictive value of non-fluorescent tissue at the biopsy level
Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among the non-fluorescent tissue adjacent to fluorescent tissue areas and the tumor distant cortex with respect to tumor (if available).
Time frame: 1 day
Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).
Sensitivity as percentage of actual positives(True positive fraction/True positive fraction + False negative fraction)and specificity as percentage of actual negatives of fluorescence detection (True negative fraction/False positive fraction + True negative fraction) at the biopsy level (if available).
Time frame: 1 day
Safety
AEs during study period (Day 0 to Day 28), laboratory parameter, vital signs, EKG, pO2
Time frame: 28 days
Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2）
Pharmacokinetic parameters of 5-ALA and PPVX (Cmax, AUCt, tmax, t1/2）
Time frame: 2 days
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