UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007867 |
|---|---|
| Receipt number | R000008676 |
| Scientific Title | research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2019/06/04 16:49:02 |
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Basic information
Public title
research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm
Acronym
radiation therapy for giant and/or thrombosed cerebral aneurysm
Scientific Title
research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm
Scientific Title:Acronym
radiation therapy for giant and/or thrombosed cerebral aneurysm
Region
| Japan |
Condition
Condition
giant and/or thrombosed cerebral aneurysms that grow after surgical treatment
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of radiation therapy for surgically-treated growing giant and/or thrombosed cerebral aneurysms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
growth of aneurysm
rupture of aneurysm
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Hypofractionated Stereotactic Radiation Therapy
35Gy/5fr.
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
1)unruptured giant and/or thrombosed aneurysms not applicable to direct or endovascular surgery
2)aneurysmal grwoth was confirmed with CT or MRI
3)wrriten informed consent
Key exclusion criteria
1)ruptured aneurysms
2)history of radiation therapy or in radiation therapy for head disease
3)patients associated with stenotic cerebral artery in the vicinity of aneurysm
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyoto university Graduate School of Medicine
Division name
Neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL
075-751-3653
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuimichi |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto university Graduate School of Medicine
Division name
Neurosurgery
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
TEL
075-751-3459
Homepage URL
kazuy@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neuosurgery, Kyoto university Graduate School of Medicine
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
Kyoto University Hospital Ethics Committe
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 07 | 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 | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008676
