UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013790 |
|---|---|
| Receipt number | R000016099 |
| Scientific Title | Quantitative susceptibility mapping research |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2024/10/30 09:15:11 |
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Basic information
Public title
Quantitative susceptibility mapping research
Acronym
Quantitative susceptibility mapping research
Scientific Title
Quantitative susceptibility mapping research
Scientific Title:Acronym
Quantitative susceptibility mapping research
Region
| Japan |
Condition
Condition
healthy volunteer, hepatic dysfunction
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate magnetic susceptibility quantitatively at each MR units with different static magnetic fields
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
each after MR scanning
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
| Device,equipment |
Interventions/Control_1
Healthy volunteers will be scanned at several MR units. Patients will be scanned at one MR unit. The data will be analyzed quantitatively.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
patients with hepatic dysfunction
Key exclusion criteria
Contraindication for MR scan
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Togashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3760
nmdioffice@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Fushimi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
81757513760
Homepage URL
nmdioffice@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital, Ethics Committee
Address
Yoshidakonoecho Sakyoku Kyoto
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
Other administrative information
Date of disclosure of the study information
| 2014 | 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
190
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
| 2014 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 06 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016099
