UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049912 |
|---|---|
| Receipt number | R000056815 |
| Scientific Title | Measurement of intramedullary blood flow in the humeral capitellum by MRI |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2022/12/23 11:59:40 |
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Basic information
Public title
Measurement of intramedullary blood flow in the humeral capitellum by MRI
Acronym
Measurement of intramedullary blood flow in the humeral capitellum by MRI
Scientific Title
Measurement of intramedullary blood flow in the humeral capitellum by MRI
Scientific Title:Acronym
Measurement of intramedullary blood flow in the humeral capitellum by MRI
Region
| Japan |
Condition
Condition
osteochondritis dissecans of the elbow
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of intramedullary blood flow in capitulum of the elbow by MRI using the ASL method in patients with OCD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow blood flow in capitulum of the elbow
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
MRI scan
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are able to rest for about 1 hour during the MRI examination.
Patients who do not have any contraindications to MRI examinations.
Patients with OCD who are visiting Tokushima university hospital
Key exclusion criteria
Persons with contraindications to MRI examinations
Patients who are unable to remain at rest for about 1 hour during the MRI examination.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yokoyama |
Organization
Tokushima university hospital
Division name
Department of Orthopaedics
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City
TEL
088-631-3111
kyokoyama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Yokoyama |
Organization
Tokushima university hospital
Division name
Department of Orthopaedics
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City
TEL
088-631-3111
Homepage URL
kyokoyama@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedics, Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedics, Tokushima University Hospital
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
Clinical Research Center for Developmental Therapeutics
Address
2-50-1 Kuramoto-cho, Tokushima City
Tel
088-633-8512
first-ec@tokushima-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
| 2023 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056815
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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