UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002497 |
|---|---|
| Receipt number | R000002992 |
| Scientific Title | Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma : prospective non-controlled study. |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2013/12/27 12:17:11 |
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Basic information
Public title
Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma : prospective non-controlled study.
Acronym
Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma.
Scientific Title
Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma : prospective non-controlled study.
Scientific Title:Acronym
Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma.
Region
| Japan |
Condition
Condition
Malignant brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Localization of malignant brain tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Evaluation of the tumor resection rate
Key secondary outcomes
Analysis of patients prognosis and side effects
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
| Medicine |
Interventions/Control_1
Oral administration of 5-aminolevulinic acid one hour before operation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gadolinium enhanced brain tumors on magnetic resonance images
Key exclusion criteria
Porphyria
Patients who did not agree with this study
Patients whom doctors decided as not a candidate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Tachibana |
Organization
Kanazawa Medical University
Division name
Department of Neurosurgery
Zip code
Address
1-1Daigaku, Uchinada, Kahoku-gun, Ishikawa, Japan
TEL
076-286-3511
neurosur@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Akai |
Organization
Kanazawa Medical University
Division name
Department of Neurosurgery
Zip code
Address
1-1Daigaku, Uchinada, Kahoku-gun, Ishikawa, Japan
TEL
076-286-3511
Homepage URL
neurosur@kanazawa-med.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 15 | Day |
Last modified on
| 2013 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002992
