UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021092 |
|---|---|
| Receipt number | R000024332 |
| Scientific Title | Assessment of hepatic iron overload by MRI IDEAL IQ method in chronic liver diseases. |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2017/11/15 21:17:30 |
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Basic information
Public title
Assessment of hepatic iron overload by MRI IDEAL IQ method in chronic liver diseases.
Acronym
Assessment of hepatic iron overload by MRI in chronic liver diseases.
Scientific Title
Assessment of hepatic iron overload by MRI IDEAL IQ method in chronic liver diseases.
Scientific Title:Acronym
Assessment of hepatic iron overload by MRI in chronic liver diseases.
Region
| Japan |
Condition
Condition
Patients with chronic liver diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the imact of iron overload on pathogenesis of chronic liver diseases by using MRI IDEAL IQ method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess whether iro overload obtained by MRI IDEAL IQ method affect the pathogenesis of chronic liver diseases.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who are scheduled to undergo liver biopsy or hepatectomy at our institution, provide a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria
1. Patients with anti-coagulation therapy
2. MRI examination is impossible (ex. Installation of pacemaker, claustrophobia)
3. Pregnant patients
4. In the opinion of the investigator, patient is unsuitable as a study subject.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2640
nakajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kento Imajo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2640
Homepage URL
kento318@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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
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
| 2016 | Year | 02 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess whether iron overload obtained y MRI IDEAL IQ method affect on pathogenesis of chronic liver diseases.
Management information
Registered date
| 2016 | Year | 02 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024332
