UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of hepatic iron overload by MRI IDEAL IQ method in chronic liver diseases.
Title of the study (Brief title)	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	Atsushi Nakajima
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	Kento Imajo
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Homepage URL
Email	kento318@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 12 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024332