UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018778 |
|---|---|
| Receipt number | R000021442 |
| Scientific Title | High-resolution magnetic resonance imaging for diagnosis and pathophysiologic analysis of lymphatic diseases |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2021/03/01 17:46:31 |
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Basic information
Public title
High-resolution magnetic resonance imaging for diagnosis and pathophysiologic analysis of lymphatic diseases
Acronym
High-resolution magnetic resonance imaging for lymphatic diseases
Scientific Title
High-resolution magnetic resonance imaging for diagnosis and pathophysiologic analysis of lymphatic diseases
Scientific Title:Acronym
High-resolution magnetic resonance imaging for lymphatic diseases
Region
| Japan |
Condition
Condition
Lymphatic diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Surgery in general |
| Gastrointestinal surgery | Radiology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish MR imaging method for diagnosis and pathophysiologic analysis of lymphatic diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of lymphatic diseases
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Contrast enhanced MR imaging for lymphatic system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have or are suspected of having lymphatic diseases.
Key exclusion criteria
1. Pacemakers and implantable defibrillators
2. MRI-incompatible devices
3. Claustrophobia
4. Renal impairment (estimated glomerular filtration rate < 30mL/min/1.73m2)
5. Past anaphylactic reaction to gadolinium-based contrast agents
6. Pregnancy or suggestive of pregnancy
7. Patients in need of urgent care
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shigeyoshi |
| Middle name | |
| Last name | Soga |
Organization
National Defense Medical College
Division name
Department of Radiology
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1689
ssoga@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Shigeyoshi |
| Middle name | |
| Last name | Soga |
Organization
National Defense Medical College
Division name
Department of Radiology
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1689
Homepage URL
ssoga@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
3-2 Namiki, Tokorozawa
Tel
0429951211
rinri@ndmc.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
| 2015 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
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
Main results already published
Date of protocol fixation
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 23 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021442
