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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029656
Receipt No. R000033706
Scientific Title Development of arterial spin labeling MRI in abdominal organs
Date of disclosure of the study information 2018/01/01
Last modified on 2017/11/02

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Basic information
Public title Development of arterial spin labeling MRI in abdominal organs
Acronym Abdominal ASL-MRI study
Scientific Title Development of arterial spin labeling MRI in abdominal organs
Scientific Title:Acronym Abdominal ASL-MRI study
Region
Japan

Condition
Condition uterine disease
renal disease
Classification by specialty
Nephrology Obsterics and gynecology Radiology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate clinical utility of arterial spin labeling-MRI for uterine and renal disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of perfusion data measured by arterial spin labeling-MRI and imaging findings of other conventional modalities.
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
Device,equipment
Interventions/Control_1 Acquisition of arterial spin labeling MRI by non-commercial MRI sequence.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Healthy subjects
Patients with renal disease
Patients with uterine disease
Key exclusion criteria none
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Kosaka
Organization University of Fukui
Division name Department of Radiology
Zip code
Address 23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui, Japan
TEL 0776618371
Email nkosaka@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Kosaka
Organization University of Fukui
Division name Department of Radiology
Zip code
Address 23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui, Japan
TEL 0776618371
Homepage URL
Email nkosaka@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

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
Address
Tel
Email

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
2018 Year 01 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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 24 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
2017 Year 10 Month 22 Day
Last modified on
2017 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033706

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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