UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053651 |
|---|---|
| Receipt number | R000061234 |
| Scientific Title | Noninvasive diagnosis of oxygen metabolism using CEST-MRI |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/19 23:00:25 |
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Basic information
Public title
Detection of Brain Oxygen Supply Issues with New MRI Technology
Acronym
MRI and Brain Oxygen Supply
Scientific Title
Noninvasive diagnosis of oxygen metabolism using CEST-MRI
Scientific Title:Acronym
CEST-MRI and oxygen metabolism
Region
| Japan |
Condition
Condition
Moyamoya disease, healthy volunteers
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a new CEST method (pH-CEST) that accurately measures the pH within brain tissue using non-invasive MRI without injections or exposure, and to establish it as a new diagnostic method for brain oxygen metabolism disorders.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of CEST-MRI and Brain Oxygen Metabolism Evaluation Test (15O-gas PET)
Comparison of CEST-MRI in patients and healthy participants
Comparison of CEST-MRI in patients before and after surgery
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
<For Moyamoya Disease Patients>
This study targets patients who meet all of the following criteria: 1. Age 16 to under 65 on the day of consent to participate in this study 2. Neuro-radiologically confirmed bilateral or unilateral Willis' circle occlusion (Moyamoya disease) 3. No neurological findings (such as aphasia, agnosia, etc.) that significantly affect neuropsychological testing 4. Mostly independent in daily life (modified Rankin scale 0-3) 5. Scheduled to undergo necessary brain oxygen metabolism evaluation test (15O-gas PET) for medical treatment 6. Consent to participate in the study has been obtained through sufficient informed consent
<For Healthy Research Participants>
The study targets those who meet all of the following criteria and have obtained consent to participate in the study: 1. Patients aged 18 to under 65 on the day of consent to participate in this study 2. Independent in daily life (modified Rankin scale 0-1) 3. No neurological findings (such as aphasia, agnosia, etc.) that affect neuropsychological testing 4. No history of neurological diseases (including moderate to severe head injuries) 5. Consent to participate in the study has been obtained through sufficient informed consent
Key exclusion criteria
Patients with Moyamoya syndrome
Patients who may suffer health damage or mental distress due to metal in the body or claustrophobia during MRI
Patients and healthy research subjects who have brain organic diseases other than Moyamoya disease that may affect the analysis results
Patients with severe systemic diseases (terminal cancer, renal failure, cirrhosis, etc.)
Other patients and healthy research subjects were deemed ineligible by the study physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Hara |
Organization
Tokyo Medical and Dental University
Division name
Department of Neurosurgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyoku, Tokyo
TEL
0358035266
shara.nsrg@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Hara |
Organization
Tokyo Medical and Dental University
Division name
Department of Neurosurgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyoku, Tokyo
TEL
0358035266
Homepage URL
shara.nsrg@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Magnetic Resonance in Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyoku
Tel
03-5803-5776
info.bec@tmd.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 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtain CEST-MRI images for both patients and healthy individuals
Management information
Registered date
| 2024 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061234
