UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007672 |
|---|---|
| Receipt number | R000005358 |
| Scientific Title | Pathological analysis of brain tumors using FDG and 11C-methionine PET |
| Date of disclosure of the study information | 2012/04/05 |
| Last modified on | 2024/04/14 09:26:46 |
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Basic information
Public title
Pathological analysis of brain tumors using FDG and 11C-methionine PET
Acronym
Pathological analysis of brain tumors using FDG and 11C-methionine PET
Scientific Title
Pathological analysis of brain tumors using FDG and 11C-methionine PET
Scientific Title:Acronym
Pathological analysis of brain tumors using FDG and 11C-methionine PET
Region
| Japan |
Condition
Condition
Brain tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Malignant brain tumors are infiltrative in its nature, making it extremely difficult to assess the tumor margin in the white matter of the brain. In this study, the investigators attempt to elucidate the possibility of using both FDG and 11C-methionine PET for the assessment of tumor cell invasion into the white matter of the brain using a voxel-wise analytical method in brain tumor patients.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Imaging and analysis of tumor cell invasion into the white matter
Key secondary outcomes
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
11C-methinoine PET
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients harboring either meningiomas or gliomas
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Hashimoto |
Organization
Osaka University Graduate School of Medicine
Division name
Neurosurgery
Zip code
Address
2-2 Yamadaoka Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Hospital
Division name
Clinical research center
Zip code
Address
TEL
Homepage URL
obata@hp-crc.med.osaka-u.ac.jp
Sponsor or person
Institute
Departement of Neurosurgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 04 | Month | 05 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | 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
| 2012 | Year | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005358
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
