UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056088 |
|---|---|
| Receipt number | R000064081 |
| Scientific Title | Evaluation of the Utility of Qualitative and Quantitative Assessment Using MR Neurography in Neurological Disorders and Neurogenic Tumors |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 14:41:40 |
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Basic information
Public title
Study on the Utility of Qualitative and Quantitative Assessment Methods Using MR Neurography for Neurological Disorders
Acronym
MRN Assessment in Neurological Disorders
Scientific Title
Evaluation of the Utility of Qualitative and Quantitative Assessment Using MR Neurography in Neurological Disorders and Neurogenic Tumors
Scientific Title:Acronym
MRN Assessment in Neurological Disorders
Region
| Japan |
Condition
Condition
Neurological Disorders, Neurogenic Tumors
Classification by specialty
| Neurology | Orthopedics | Radiology |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to enhance the early detection of lesions, assess disease progression, monitor treatment effectiveness, and improve prognostic accuracy through qualitative and quantitative evaluations using MR neurography for neurological disorders and neurogenic tumors. As an exploratory study, it seeks to calculate quantitative values that serve as indicators for new diagnostic and assessment methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative assessment of neurological disorders and neurogenic tumors
Key secondary outcomes
Association between disease activity in neurological disorders, malignancy in neurogenic tumors, and quantitative values (T2 values and ADC values)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Acquire MR neurography images.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients at Keio University Hospital undergoing MRI examinations for neurological disorders and neurogenic tumors.
Key exclusion criteria
1) Patients who have indicated that they do not consent to the use of their personal information in this study.
2) Patients for whom MRI examination continuation is expected to be difficult due to body movement.
3) Patients in whom image distortion in the target area is anticipated due to internal metal.
4) Patients for whom MRI examination is deemed contraindicated.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Nozaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nozaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Arai |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
marai@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Manabu Arai
Funding Source
Organization
Keio University
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
Keio University School of Medicine Ethics Committee
Address
35 shinanomachi, Shinjuku-ku,Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
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 | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2028 | 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 | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064081
