Unique ID issued by UMIN | UMIN000033617 |
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Receipt number | R000038334 |
Scientific Title | 5-ALA and VLD-EX guided resection of malignant brain tumor |
Date of disclosure of the study information | 2018/08/03 |
Last modified on | 2018/08/03 04:41:37 |
5-ALA and VLD-EX guided resection of malignant brain tumor
5-ALA and VLD-EX guided resection of malignant brain tumor
5-ALA and VLD-EX guided resection of malignant brain tumor
5-ALA and VLD-EX guided resection of malignant brain tumor
Japan |
Malignant brain tumor
Neurosurgery |
Malignancy
NO
Detection of protoporphyrin IX by VLD-EX under white light in removal of malignant brain tumor
Safety,Efficacy
Exploratory
Phase II
Detection rate of PpIX under white light
Detection rate of PpIX
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
Detection of PpIX by VLD-EX after intake of 5-ALA 20mg/kg
15 | years-old | <= |
90 | years-old | > |
Male and Female
Patient before surgery of malignant brain tumor tumor
Age >= 15
Written informed consent
1)Porphyria or orphyrin hypersensitivity
2) Cr >= 2.0
3) ALT >= 100, AST >= 100, TB >= 3.0
4) Patient with other malignant tumor
5) Pregnant or lactating woman
160
1st name | |
Middle name | |
Last name | Yoshitaka Narita |
National Cancer Center Hospital
Department of Neurosurgery and Neuro-Oncology
5-1-1 Tsukiji Chuo-ku, Tokyo
03-3542-2511
yonarita@ncc.go.jp
1st name | |
Middle name | |
Last name | Yoshitaka Narita |
National Cancer Center Hospital
Department of Neurosurgery and Neuro-Oncology
5-1-1 Tsukiji Chuo-ku, Tokyo
03-3542-2511
yonarita@ncc.go.jp
National Cancer Center Hospital
National Cancer Center Hospital
Other
Japan
NO
2018 | Year | 08 | Month | 03 | Day |
Unpublished
Completed
2012 | Year | 11 | Month | 06 | Day |
2012 | Year | 11 | Month | 14 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 08 | Month | 03 | Day |
2018 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038334
Research Plan | |
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Research case data | |
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