UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020042 |
|---|---|
| Receipt number | R000023113 |
| Scientific Title | Efficacy of perfusion MR enterography assessing intestinal lesions in patients with Crohn's disease |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2015/12/02 19:06:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of perfusion MR enterography assessing intestinal lesions in patients with Crohn's disease
Acronym
Efficacy of perfusion MR enterography assessing intestinal lesions in patients with Crohn's disease
Scientific Title
Efficacy of perfusion MR enterography assessing intestinal lesions in patients with Crohn's disease
Scientific Title:Acronym
Efficacy of perfusion MR enterography assessing intestinal lesions in patients with Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of perfusion MR enterography assessing intestinal lesions in patients with Crohn's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the relationship between the value of Ktrans and fis by perfusion MR enterography and endoscopic findings
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
perfusion MR enterography
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Crohn's disease patients treated in Kyoto University Hospital
2. more than 16 years old
3. treated with anti-TNF-alpha antibody
4. received colonoscopy or enteroscopy
Key exclusion criteria
1. Crohn's disease patients with severe activity
2. pregnant patients or suspected one
3. the patients did not agree this study
4. the patients who is difficult for MRI such as allergy, renal failure, indwelling object made of metal, and claustrophobia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakase |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
hiropy_n@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamada |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterologoly and Hepatology
Zip code
Address
Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
Homepage URL
yamadasa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
University Grants
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
Address
Tel
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
| 2015 | Year | 12 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 02 | Day |
Last modified on
| 2015 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023113
