UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029521 |
|---|---|
| Receipt number | R000033585 |
| Scientific Title | Association of MRI features with IDH mutation status in patients with glioblastoma. |
| Date of disclosure of the study information | 2017/10/17 |
| Last modified on | 2021/10/19 15:55:06 |
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Basic information
Public title
Association of MRI features with IDH mutation status in patients with glioblastoma.
Acronym
MRI for IDH mutation in glioblastoma
Scientific Title
Association of MRI features with IDH mutation status in patients with glioblastoma.
Scientific Title:Acronym
MRI for IDH mutation in glioblastoma
Region
| Japan |
Condition
Condition
glioblastoma
Classification by specialty
| Neurology | Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identihy MRI findings and their combinations associated with IDH mutant status in glioblastoma.
Basic objectives2
Others
Basic objectives -Others
diagnostic efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
tumor size, enhancement, non-enhanced region, necrosis size, edema size, location, ADC, rCBV.
Key secondary outcomes
subgroup analysis stratified by age, gender, etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Glioblastoma confirmed by postoperative pathological exanination.
2. Preoperative MRI for glioblastoma.
- T1WI
- contrasted T1WI
- transverse T2WI
- FLAIR
- DWI
- DSC MR perfusion (if available)
3. IDH mutation tests of surgical specimen.
4. Twenty years or older at the time of preoperative MRI.
Key exclusion criteria
1. Medication which affects MRI e.g. steroids.
2. Tissue type other than glioblastoma e.g. giant cell glioblastoma, gliosarcoma, epithelioid glioblastoma.
3. No transverse T2WI.
4. Not evaluable for artifacts.
5. Recurrence after treatment.
6. Judged ineligible by investigators.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | Hirai |
Organization
University of Miyazaki
Division name
Department of Radiology, Faculty of Medicine
Zip code
8891692
Address
5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, 889-1692
TEL
0985-85-2807
toshinorh@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshinori |
| Middle name | |
| Last name | Hirai |
Organization
University of Miyazaki
Division name
Department of Radiology, Faculty of Medicine
Zip code
8891692
Address
5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, 889-1692
TEL
0985-85-2807
Homepage URL
toshinorh@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committee at university of Miyazaki
Address
5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, 889-1692
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
宮崎大学（宮崎県）、北海道大学（北海道）、山形大学（山形県）、福島県立医科大学（福島県）、東京医科歯科大学（東京都）、順天堂大学（東京都）、山梨大学（山梨県）、埼玉県立がんセンター（埼玉県）、東京慈恵医科大学付属柏病院（千葉県）、亀田総合病院（千葉県）、筑波大学（茨城県）、横浜市立大学附属病院（神奈川県）、群馬大学（群馬県）、新潟大学（新潟県）、京都大学（京都府）、大阪大学（大阪府）、兵庫医科大学（兵庫県）、奈良県立医科大学（奈良県）、鳥取大学（鳥取県）、徳島大学（徳島県）、産業医科大学（福岡県）、長崎大学（長崎県）、熊本大学（熊本県）、大分大学（大分県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
347
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
in preparation for publication
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 29 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
RSNA2020
(11/29 to 12/5, Chicago, IL, US)
NR-1A-68
Estimation of IDH Mutation Status of Glioblastoma with Clinical and MR
Imaging Parameters
Minako Azuma Department of Radiology, Faculty of Medicine, University of
Miyazaki, Japan
Management information
Registered date
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033585
| 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 |
