UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052886 |
|---|---|
| Receipt number | R000060346 |
| Scientific Title | Evaluation of pancreatic endocrine and exocrine function using T1 mapping on MRI |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/23 15:42:18 |
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Basic information
Public title
Evaluation of pancreatic endocrine and exocrine function using T1 mapping on MRI
Acronym
Evaluation of pancreatic function with T1 mapping
Scientific Title
Evaluation of pancreatic endocrine and exocrine function using T1 mapping on MRI
Scientific Title:Acronym
Evaluation of pancreatic function with T1 mapping
Region
| Japan |
Condition
Condition
chronic pancreatitis and autoimmune pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether T1 relaxation time obtained by MRI T1 mapping of the pancreas correlates with pancreatic endocrine and exocrine function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between pancreatic MRI T1 mapping and pancreatic endocrine and exocrine function
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pancreatic disease group: cases with chronic pancreatic disease (chronic pancreatitis or autoimmune pancreatitis).
Cases who have definite diagnosis, probable diagnosis, or early-stage chronic pancreatitis according to the Chronic Pancreatitis Clinical Diagnostic Criteria 2019.
Cases who meet the International consensus diagnostic criteria or the clinical diagnostic criteria for autoimmune pancreatitis 2018.
Control group: cases who have no pancreatic abnormality on imaging modality or blood tests, and who undergo MRI imaging.
(1) Cases who are 20 years of age or older at the time of obtaining consent.
(2) Cases who understand the contents of the examination and agree to participate in this study.
(3) Cases who are capable of collecting appropriate stool samples.
Key exclusion criteria
(1) Cases who are unable to perform MRI examinations due to metal in the body or claustrophobia.
(2) Cases who cannot collect an appropriate stool specimen due to chronic diarrhea or other symptoms.
(3) Cases with malignant tumors of the pancreaticobiliary organ indicated by other imaging tests.
(4) Cases with severe pancreatic atrophy or multiple pancreatic cysts that prevent measurement of T1 value.
(5) Cases with a history of pancreatectomy.
(6) Cases who is judged to be inappropriate for participating this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kuraishi |
Organization
Shinshu university school of medicine
Division name
Department of gastroenterology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2805
yasuhiro@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kuraishi |
Organization
Shinshu university school of medicine
Division name
Department of gastroenterology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2805
Homepage URL
yasuhiro@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu university school of medicine
Address
3-1-1, Asahi, Matsumoto, Nagano
Tel
0263-37-2805
yasuhiro@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | 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
None
Management information
Registered date
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060346
