UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056445 |
|---|---|
| Receipt number | R000064484 |
| Scientific Title | Evaluation of the physiological change in muscles with T2 map and intravoxel incoherent motion (IVIM): the difference between before and after the exercise |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2024/12/13 06:47:56 |
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Basic information
Public title
Evaluation of the physiological change in muscles using quantitative MRI analysis
Acronym
M-QMRI
Scientific Title
Evaluation of the physiological change in muscles with T2 map and intravoxel incoherent motion (IVIM): the difference between before and after the exercise
Scientific Title:Acronym
M-T2 map/IVIM
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Thigh MRI T2 map and intravoxel incoherent motion (IVIM) will be performed in healthy subjects to investigate whether changes in signal values occur before and after exercise, and to verify these mechanism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thigh MRI T2 map and intravoxel incoherent motion (IVIM)
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
Healthy subjects are asked to do exercises (bending and stretching exercise 15 times x 20 sets) and bed rest, and a thigh MRI is taken before and after them. 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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 20 to 40 with written informed consent
Key exclusion criteria
1. People who have a history of thigh muscle injury, treatment, or surgery, or patients who have been pointed out to have some kind of abnormality in muscles.
2. Cases with some symptoms in the thigh muscles.
3. Cases where sports or exercise is prohibited or cannot be done for some reason.
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
40
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
049-276-1265
ldeso5rbdlayids9taiy@gmail.com
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
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
Address
38 Morohongou, Moroyama-machi, Iruma-gun
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
| 2024 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 12 | Month | 13 | 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=R000064484
