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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018778
Receipt No. 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 2019/08/26

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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
Email 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
Email ssoga@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

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
Email 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
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
2034 Year 03 Month 31 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
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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