UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041988 |
|---|---|
| Receipt number | R000047892 |
| Scientific Title | prospective evaluation of cine MRI and abdominal symptoms |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2025/04/25 15:27:26 |
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Basic information
Public title
evaluation of cine MRI and abdominal symptoms
Acronym
evaluation of cine MRI and abdominal symptoms
Scientific Title
prospective evaluation of cine MRI and abdominal symptoms
Scientific Title:Acronym
prospective evaluation of cine MRI and abdominal symptoms
Region
| Japan |
Condition
Condition
Patients with abdominal symptoms (functional dyspepsia, chronic constipation) and healthy volunteers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform visual and objective evaluation of intestinal volume and localization using abdominal cine MRI and to examine the relationship with abdominal symptoms.
To compare the intestinal volume, intestinal diameter, and peristalsis before and after the test meal in healthy subjects and patients with abdominal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of intestinal volume, diameter, and peristalsis before and after the test meal in healthy subjects and patients with abdominal symptoms (functional dyspepsia, chronic constipation) (Stomach, duodenum, small intestine, colon, rectum)
Key secondary outcomes
Relationship between intestinal volume, diameter, peristalsis and abdominal symptom before and after the test meal, evaluation of gastric emptying
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
| Food |
Interventions/Control_1
test meal
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
Patients with abdominal symptoms (functional dyspepsia, chronic constipation) who have undergone Upper endoscopy or upper gastrointestinal barium examination for functional dyspepsia / lower endoscopy or barium enema examination for chronic constipation and are excluded from organic diseases.
or healthy subjects without abdominal symptoms.
Written informed consent provided for study participation
Key exclusion criteria
1)Organic constipation(colorectal cancer, inflammatory bowel disease, megacolon)
2)After gastrointestinal tract resection.
3)Advanced gastric cancer, advanced colorectal cancer
4)Active peptic ulcer
5)Non-MRI compatible metals such as pacemakers and artificial joints or who are undergoing tattooing
Patients with claustrophobia
6)Patients who are allergic to test meal
7) Considered by the principal investigator to be ineligible.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Takeda |
Organization
Juntendo university school of medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku
TEL
03-3813-3111
t-takeda@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Takeda |
Organization
Juntendo University school of Medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku
TEL
0338133111
Homepage URL
t-takeda@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University school of Medicine
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
Juntendo University school of Medicine Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2020 | Year | 10 | Month | 02 | 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
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047892
