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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033617
Receipt No. R000038334
Official scientific title of the study 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

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Basic information
Official scientific title of the study 5-ALA and VLD-EX guided resection of malignant brain tumor
Title of the study (Brief title) 5-ALA and VLD-EX guided resection of malignant brain tumor
Region
Japan

Condition
Condition Malignant brain tumor
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Detection of protoporphyrin IX by VLD-EX under white light in removal of malignant brain tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Detection rate of PpIX under white light
Key secondary outcomes Detection rate of PpIX
Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Detection of PpIX by VLD-EX after intake of 5-ALA 20mg/kg
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patient before surgery of malignant brain tumor tumor
Age >= 15
Written informed consent
Key exclusion criteria 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
Target sample size 160

Research contact person
Name of lead principal investigator Yoshitaka Narita
Organization National Cancer Center Hospital
Division name Department of Neurosurgery and Neuro-Oncology
Address 5-1-1 Tsukiji Chuo-ku, Tokyo
TEL 03-3542-2511
Email yonarita@ncc.go.jp

Public contact
Name of contact person Yoshitaka Narita
Organization National Cancer Center Hospital
Division name Department of Neurosurgery and Neuro-Oncology
Address 5-1-1 Tsukiji Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email yonarita@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 03 Day

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 11 Month 06 Day
Anticipated trial start date
2012 Year 11 Month 14 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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