UMIN-CTR Clinical Trial

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

Hepatic tumor

Classification by specialty

Hepato-biliary-pancreatic medicine

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kinki University Faculty of Medicine

Institute

Department

Personal name

Organization

Bayer Yakuhin Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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.

Date of disclosure of the study information

2013

Year

07

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2013

Year

07

Month

18

Day

Last modified on

2020

Year

07

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013143