UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036504 |
|---|---|
| Receipt number | R000041591 |
| Scientific Title | The utility of imaging findings using new sequence of MRI in brain tumor |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2021/04/15 14:33:30 |
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Basic information
Public title
The utility of imaging findings using new sequence of MRI in brain tumor
Acronym
The utility of imaging findings using new sequence of MRI in brain tumor
Scientific Title
The utility of imaging findings using new sequence of MRI in brain tumor
Scientific Title:Acronym
The utility of imaging findings using new sequence of MRI in brain tumor
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the utility of MR imaging findings using new sequence in brain tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) To correlate signal intensity of APT imaging and histopathological findings in brain tumor.
2) To correlate signal intensity of APT imaging and imaging findings on other sequences after chemotherapy and/or radiation therapy.
3) To correlate signal intensity of eASL and histopathological findings in brain tumor.
4) To correlate signal intensity of eASL and imaging findings on other sequences after chemotherapy and/or radiation therapy.
Key secondary outcomes
1) To correlate signal intensity of eASL and conventional ASL.
2) To compare the image quality of eASL and signal intensity of dynamic susceptibility contrast in brain tumor.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who agree and write informed consent form
If subjects are child, their parent or guardian write informed consent form
2) patient who undergo MRI imaging for medical treatment
3) patients who have brain tumors or are suspected to have brain tumors
4) patient who received chemotherapy and radiation therapy after brain tumor surgery
Key exclusion criteria
1) patients who cannot lie down for 1 hour
2) pregnant patients
3) claustrophobia
4) patients who are considered not to be suitable for the research by research representative
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Fujii |
Organization
Tottori university
Division name
Department of radiology
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6637
sfujii@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Fujii |
Organization
Tottori university
Division name
Department of radiology
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6637
Homepage URL
sfujii@tottori-u.ac.jp
Sponsor or person
Institute
Tottori university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
institutional reveiw board
Address
36-1, Nishi-cho, Yonago
Tel
0859-38-7108
me-kenkyu@adm.tottori-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 04 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041591
