UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056727 |
|---|---|
| Receipt number | R000063633 |
| Scientific Title | Study on 'Semi-Fowler Position MRI' for Diagnosing Cerebrospinal Fluid Leak in Minors |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2025/01/15 23:07:05 |
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Basic information
Public title
Study on 'Semi-Fowler Position MRI' for Diagnosing Cerebrospinal Fluid Leak in Minors
Acronym
Study on 'Semi-Fowler Position MRI' for Diagnosing Cerebrospinal Fluid Leak in Minors
Scientific Title
Study on 'Semi-Fowler Position MRI' for Diagnosing Cerebrospinal Fluid Leak in Minors
Scientific Title:Acronym
SFM study
Region
| Japan |
Condition
Condition
cerebrospinal fluid hypovolemia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regarding cerebrospinal fluid (CSF) leakage syndrome, in Japan, the "Imaging Criteria for CSF Leakage Syndrome" was established in 2011. In 2016, medical insurance coverage became available for the blood patch treatment, which involves sealing the presumed leakage site. In 2019, the "Clinical Practice Guidelines for CSF Leakage Syndrome" were developed, marking some progress. However, diagnosing this condition still remains challenging in many cases. Against this backdrop, we are conducting clinical research on CSF hypovolemia.
In patients with CSF hypovolemia, it is possible that the brain, spinal cord, and the dura mater (the sac containing CSF) may be deflated. Patients suspected of having CSF hypovolemia typically undergo MRI scans in the supine position (lying face-up) for diagnostic purposes. In this study, in addition to the usual supine position, we perform additional MRI scans with the upper body slightly elevated. If CSF hypovolemia causes deflation of the brain, spinal cord, or dura mater, it is expected that the shape of the dura mater will change between the two postures.
In a previous clinical study involving upper-body-elevated MRI scans, we targeted participants aged 18 years and older, using healthy individuals as controls. It was confirmed that the shape of the dura mater did not change in healthy individuals with postural changes. However, in patients with CSF hypovolemia, relatively frequent changes in the dura mater's shape due to its collapse were observed. This suggests that this imaging method could be effective as a screening tool for CSF hypovolemia. Additionally, since no adverse events were observed, we have decided to conduct a clinical study targeting participants aged 10 to under 18 years.
Compared to standard MRI scans, posture-change MRI provides more information in cases of CSF hypovolemia and could significantly enhance diagnostic accuracy for the condition. Establishing this method would be of great significance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the dura mater in standard MRI imaging with that in imaging performed with the upper body elevated. The comparison will be conducted quantitatively if possible; however, the primary objective is to confirm the presence or absence of visible changes. The focus is on observing changes in the images caused by the change in posture.
Key secondary outcomes
1. Measurement of the anteroposterior diameter of the lumbosacral dura mater in sagittal imaging of full-spine MRI.
2. Quantification of signal intensity changes in the lumbosacral region caused by postural variation.
3. Measurement of the angle of the dura mater tip at the terminal end of the lumbosacral dura mater.
4. Evaluation of safety.
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
MRI scans are generally performed in the supine position. In this study, after obtaining informed consent, we will first conduct an MRI scan in the supine position. Following this, under the same conditions, we will perform an additional MRI scan with the upper body slightly elevated. The standard supine MRI scan will take approximately 15 minutes, followed by another 15-minute MRI scan with the upper body slightly raised.
The MRI images obtained in these two positions will be compared to examine changes in the shape of the dura mater, brain, spinal cord, and cerebrospinal fluid sac. These scans will be performed during a single session and will not be repeated on different days. Additionally, no contrast agents or other medications will be used.
Basic information such as sex, age at the time of consent, and medical history (particularly any history of trauma) will also be collected.
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
| 10 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Cases presenting with orthostatic headache and suspected cerebrospinal fluid (CSF) hypovolemia.
2. Participants aged 10 years or older but under 18 years.
Key exclusion criteria
1. Patients for whom MRI scanning is not possible.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School, Kochi University
Division name
Neurosurgery
Zip code
783-8505
Address
185-1 Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
0888802397
enakai@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School, Kochi University
Division name
Neurosurgery
Zip code
783-8505
Address
185-1 Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
0888802397
Homepage URL
enakai@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Ethical Review Board of Kochi Medical School
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan Kouchi
Tel
0888802180
is21@kochi-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 16 | 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
| 2024 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2025 | Year | 01 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063633
