UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048586 |
|---|---|
| Receipt number | R000055358 |
| Scientific Title | Evaluation of the physiological change in knee articular structures with T1rho/T2 mapping: the difference between before and after the exercise, and the diurnal change |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2024/12/13 06:52:59 |
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Basic information
Public title
Evaluation of the physiological change in knee articular structures using quantitative MRI analysis
Acronym
KAS-QMRI
Scientific Title
Evaluation of the physiological change in knee articular structures with T1rho/T2 mapping: the difference between before and after the exercise, and the diurnal change
Scientific Title:Acronym
KAS-T1rho/T2 mapping
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Knee joint MRI T1rho and T2 mapping will be performed in healthy subjects to investigate whether changes in signal values occur before and after exercise and with daily activities, and to verify these mechanism.
Basic objectives2
Others
Basic objectives -Others
Knee joint MRI T1rho and T2 mapping will be performed in healthy subjects to investigate whether changes in signal values occur before and after exercise and with daily activities, and to verify these mechanism.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee joint MRI (T1rho mapping, T2 mapping)
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
| Other |
Interventions/Control_1
1. Healthy subjects are asked to do exercises (jump rope 20 times x 10 sets, repetitive side jump 20 seconds x 10 sets, bending and stretching exercise 10 times x 10 sets) and bed rest, and a knee joint MRI is taken before and after them. A washout period of at least one week will be provided between each examination day.
2. Healthy subjects are asked to spend in a lying position, sitting position, and standing position for a longer time (target of 4 hours or more), and a knee joint MRI will be taken at morning (8:00 to 9:00) and evening (16:00 to 17:00). A washout period of at least one week will be provided between each examination day.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 20 to 30 with written informed consent
Key exclusion criteria
1. People who have a history of knee joint injury, treatment, or surgery, or patients who have been pointed out to have some kind of abnormality.
2. Cases with some symptoms in the knee joint.
3. Cases where sports or exercise is prohibited or cannot be done for some reason, or for some reason, standing, sitting, or lying down is prohibited or impossible.
4. Cases corresponding to MRI contraindication.
5. Cases in which MRI artifacts are likely to appear and signal values are difficult to measure.
6. History of malignant tumor
7. Those who may be pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Nagawa |
Organization
Saitama medical university
Division name
Radiology department
Zip code
3500495
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL
0492761265
radmini@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Nagawa |
Organization
Saitama medical university
Division name
Radiology department
Zip code
3500495
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1265
Homepage URL
radmini@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university
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
Saitama medical university hospital
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1354
hirb@saitama-med.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
| 2022 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055358
