UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040767 |
|---|---|
| Receipt number | R000045451 |
| Scientific Title | A diagnostic method of musculoskeletal pain using the PET-MRI. |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2021/04/13 19:47:06 |
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Basic information
Public title
A diagnostic method of musculoskeletal pain using the PET-MRI.
Acronym
PET-MRI diagnosis of musculoskeletal pain.
Scientific Title
A diagnostic method of musculoskeletal pain using the PET-MRI.
Scientific Title:Acronym
PET-MRI diagnosis of musculoskeletal pain.
Region
| Japan |
Condition
Condition
shoulder joint problems
lumbar pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
research of correlation of morphological changes and inflammation
Basic objectives2
Others
Basic objectives -Others
pathological research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation of locations between morphological diagnosis through MRI and FDG accumulation in PET
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
administration of FDG and taking lumbar MRI for the patients of shoulder joint pain
Interventions/Control_2
administration of FDG and taking shoulder MRI for the lumbago patients
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
The orthopaedic outpatients of Kyoto University Hospital aged not less than 20 years old, who are suffered from shoulder or lumbar pain, who are thought to need taking MRI for diagnosis, and who can independently express their participation in this study.
Key exclusion criteria
1) the patients who express both of shoulder and lumbar pain.
2) the patients who had surgeries in the shoulder or lumbar spine.
3) the patients who have intracephalic aneurysm clips or heart pacemakers which are contraindicated to MRI.
4) the patients whom the examiners do not think applicable.
5) the patients who show more than 200 mg/dl of blood glucose level during the examination.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryuzo |
| Middle name | |
| Last name | Arai |
Organization
Kyoto University
Division name
Department of Orthopaedic Surgery
Zip code
606-8507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto city
TEL
075-366-7734
rarai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | N/A |
| Middle name | |
| Last name | N/A |
Organization
Kyoto University Hospital
Division name
Consultation support center
Zip code
606-8507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto city
TEL
075-751-4748
Homepage URL
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
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 Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, 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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 22 | 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
| 2020 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 13 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 13 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045451
