UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060970 |
|---|---|
| Receipt number | R000069768 |
| Scientific Title | Diagnostic utility of positional (supine and prone) MRI in adult filum terminale syndrome: a case-control study |
| Date of disclosure of the study information | 2026/03/18 |
| Last modified on | 2026/03/18 10:20:00 |
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Basic information
Public title
Utility of positional (supine and prone) MRI for the diagnosis of adult filum terminale syndrome
Acronym
TFT-MRI Study
Scientific Title
Diagnostic utility of positional (supine and prone) MRI in adult filum terminale syndrome: a case-control study
Scientific Title:Acronym
TFT-MRI
Region
| Japan |
Condition
Condition
Adult filum terminale syndrome (including suspected cases)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the diagnostic utility of positional MRI (supine and prone) in adult filum terminale syndrome by quantitatively assessing conus medullaris displacement and positional indices of the filum terminale and cauda equina, and comparing these findings with those of healthy controls.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the diagnostic utility of positional MRI in adult filum terminale syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relative displacement rate (%) of the conus medullaris between supine and prone positions assessed on MRI at the time of imaging
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Case group>
Age over 18 years
Patients with low back pain, lower extremity symptoms, or urinary dysfunction diagnosed with filum terminale syndrome by a physician
No obvious filum lipoma or marked thickening on supine MRI
Availability of both supine and prone MRI for evaluation
<Healthy control group>
Age over 18 years
No low back or lower extremity symptoms
No history of lumbar spine surgery
Able to undergo MRI and provide written informed consent
Key exclusion criteria
Presence of other significant spinal pathologies such as severe lumbar spinal stenosis, large disc herniation, or spina bifida
History of extensive lumbosacral surgery or severe scoliosis making MRI evaluation difficult
Contraindications to MRI (e.g., cardiac pacemaker)
Pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Mimura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
TEL
0263372659
tettim3@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tetsuhiko |
| Middle name | |
| Last name | Mimura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
3908621
Address
3-1-1 Asahi Matsumoto Nagano 390-8621 Japan
TEL
0263372659
Homepage URL
tettim3@yahoo.co.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Tetsuhiko Mimura
Funding Source
Organization
Self funding
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
Shinshu University School of Medicine
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263-37-3099
mdrinri@shinshu-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
長野県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 18 | 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
| 2026 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center observational case-control study involving adult patients with filum terminale syndrome and healthy controls. Both retrospectively collected clinical MRI data and prospectively acquired MRI data (supine and prone positions) will be used to evaluate conus medullaris displacement and positional indices of the filum terminale and cauda equina. No intervention will be performed, and imaging assessments will be conducted independently by two blinded evaluators.
Management information
Registered date
| 2026 | Year | 03 | Month | 18 | Day |
Last modified on
| 2026 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069768
