UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060893 |
|---|---|
| Receipt number | R000069686 |
| Scientific Title | Estimation of Pelvic and Thigh Muscle Volume Using Multiplanar Reconstruction (MPR) Images from MRI |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/11 11:24:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Estimation of Pelvic and Thigh Muscle Volume from Arbitrary Cross-Sections Using MRI
Acronym
Muscle Mass Estimation Test
Scientific Title
Estimation of Pelvic and Thigh Muscle Volume Using Multiplanar Reconstruction (MPR) Images from MRI
Scientific Title:Acronym
Muscle Mass Estimation Test
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we focus on differences in the geometric morphology of muscles and aim to identify the optimal surrogate cross-section that shows the highest correlation with total muscle volume using multiplanar reconstruction (MPR) images generated from MRI data. Specifically, the gluteal muscles (gluteus maximus, gluteus medius, and gluteus minimus) will be analyzed as representative radial muscles, while the thigh muscles (e.g., quadriceps femoris and hamstrings) will be analyzed as representative fusiform muscles. Instead of limiting the analysis to conventional axial cross-sections, multiple candidate planes aligned with the muscle fiber direction will be generated. By evaluating how different combinations of plane position and orientation affect the accuracy of muscle volume estimation, the optimal surrogate cross-section for each muscle morphology will be determined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Gluteal Muscle Mass in Healthy Volunteers (Gluteus Maximus, Gluteus Medius, and Gluteus Minimus)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults (over 18 years old)
Key exclusion criteria
Individuals with a history of pelvic or thigh surgery
Individuals with underlying diseases such as hypertension or diabetes that may make it difficult to remain still during the examination
Individuals who are pregnant or may be pregnant
Individuals with metallic implants (e.g., cardiac pacemakers or ferromagnetic implants)
Individuals judged to be unsuitable for participation by the principal investigator (e.g., tattoos, cosmetic tattoos, or claustrophobia)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MASATO |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Radiological Technology
Zip code
3000394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
TEL
08012303920
takahashima@ipu.ac.jp
Public contact
Name of contact person
| 1st name | MASATO |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Radiological Technology
Zip code
3000394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
TEL
0298884000
Homepage URL
takahashima@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
Tel
0298884000
takahashima@ipu.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
| 2026 | Year | 04 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study.
Recruitment: Volunteers will be recruited via an announcement posted on the Desknets information system of Ibaraki Prefectural University of Health Sciences. Interested individuals will apply by email or telephone.
Study period: From April 1, 2026 to March 31, 2029.
Management information
Registered date
| 2026 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069686
