UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of correlation between occurrence of truncation artifact and imaging conditions in the arterial phase of Gadoxetic acid-enhanced liver dynamic MRI: Retrospective study
Acronym	Truncation ARtifact on Gadoxetic acid-Enhanced dynamic MR images in Arterial Phase: ReTrospective Study (TARGET Study)
Scientific Title	Investigation of correlation between occurrence of truncation artifact and imaging conditions in the arterial phase of Gadoxetic acid-enhanced liver dynamic MRI: Retrospective study
Scientific Title:Acronym	Truncation ARtifact on Gadoxetic acid-Enhanced dynamic MR images in Arterial Phase: ReTrospective Study (TARGET Study)
Region	Japan

Condition
Condition	Hepatic tumor
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of the present study is to retrospectively investigate the correlation between EOB-enhanced dynamic MR imaging conditions and the occurrence of truncation artifacts in EOB-enhanced dynamic MR arterial phase images for each manufacture of the major MRI scanners used in Japan in order to determine what conditions are most correlated with the occurrence of truncation artifacts.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	primary endpoint: MRI scanner-related conditions Imaging Timing Setting Technique Voxel Size Matrix K-space Ordering Data Acquisition Time (time to take arterial phase images) Reduction Factor for Parallel Imaging Flip Angle Fat Suppression Technique Magnetic Field Strength EOB administration-related conditions Rate of Administration of EOB Amount of Saline for Flushing; The correlation between the occurrence of truncation artifacts in arterial phase images after administration of EOB and these EOB-enhanced dynamic MRI imaging conditions will be statistically analyzed.
Key secondary outcomes	(1) Distribution of the scores of truncation artifacts by EOB-enhanced dynamic MRI imaging condition (2) Correlation between the conspicuity of lesions and the distribution of the scores of truncation artifacts

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patients who undergo an EOB-enhanced dynamic MRI scan performed in accordance with the product information approved in Japan during the past one year before the time when it becomes possible to start this study at each institution on and after April 1, 2013 (will be enrolled in this study consecutively in an unselected manner) (2) Patients who undergo an EOB-enhanced dynamic MRI scan at a magnetic field strength of 1.5 T or higher using a fat-suppressed 3D-gradient echo (GRE) sequence with an MRI scanner manufactured by GE, SIEMENS, PHILIPS, or TOSHIBA (3) Inpatient or outpatient (4) Male or female patients (5) Patients aged 20 or more and less than 85 years (6) Patients with a serum creatinine level below the institutional upper limit of normal (7) Patients with liver disease of any etiology (8) Patients with a body weight below 100 kg (9) Patients who are awake and alert (10) Patients prescribed with EOB in accordance with the product information approved in Japan
Key exclusion criteria	(1) Patients with documented occurrence of motion artifacts (due to inappropriate breath holding) in MR images taken before use of EOB (2) Patients with portal vein thromboembolism30) (3) Patients with multiple (10 lesions or more) or giant hepatic mass lesions (60 mm or more)30) (4) Patients in whom MRI is contraindicated (with a pacemaker implanted) (5) Patients with known hypersensitivity to gadolinium contrast media (6) Patients with bronchial asthma or serious allergies (7) Patients with serious renal impairment (8) Pregnant or nursing patients (9) Patients listed in the enrollment log redundantly (10) Any others judged ineligible for enrollment in this study by the investigator at each institution
Target sample size	1600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takamichi Murakami
Organization	Kinki University Faculty of Medicine
Division name	Department of Radiology
Zip code
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Masakatsu Tsurusaki
Organization	Kinki University Faculty of Medicine
Division name	Department of Radiology
Zip code
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Homepage URL	http://radiol.med.kindai.ac.jp/
Email

Sponsor
Institute	Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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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	近畿大学医学部附属病院（大阪）　　Kinki University Hospital(Osaka) その他、日本国内およそ40施設が本試験に参加予定。 About 40 institutions in Japan will participate in this study.

Other administrative information
Date of disclosure of the study information	2013 Year 07 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
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Results Delayed
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 09 Day
Date of IRB	2013 Year 05 Month 09 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2013 Year 11 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2014 Year 08 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other

Other related information

Prospective, consecutive, non-selective, single-arm, multi-center, non-interventional study Since this study is a retrospective, non-interventional, observational study, explanations about this study to each patient by the investigator/sub-investigator will be omitted, or informed consent from each patient will be replaced by disclosure of study-related information in compliance with the "Ethical Guidelines for Clinical Studies" published by the Ministry of Health, Labour and Welfare and the provisions at each institution. Since this study is a retrospective, non-interventional, observational study, collection of safety information, such as the occurrence of adverse events, including a follow-up assessment of such events will not be performed.

Management information
Registered date	2013 Year 07 Month 18 Day
Last modified on	2020 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013143