UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of iodine dose effect on aortic and liver enhancement in abdominal CT and on coronary artery enhancement in cardiac CT in daily medical practice
Title of the study (Brief title)	Iopamiron Abdominal and Cardiac CT enhancement study (IOPAC study)
Region	Japan

Condition
Condition	hepatocellular carcinoma coronary infarction
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of the study are to investigate the current use of Iopamiron in abdominal and coronary CT, to investigate the correlation between the dose of Iopamiron and the quality of CT images according to indices likely to affect the quality of images (weight, lean body weight, body surface area and body mass index) and to decide the optimal dose of Iopamiron.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	(1) Correlation between the contrast enhancement of the sites below and the dose of iodine according to various body size-related indices, such as sex, height, weight, lean body weight (LBW), body surface area (BSA) and body mass index (BMI), Abdominal CT Aortic enhancement in arterial phase Liver parenchyma enhancement in portal venous phase Coronary CT CT value at the left main trunk and right coronary artery after administration of Iopamiron (2) Correlation between good-enhancement and factors affecting the CT enhancement (Definition of good-enhancement) Abdominal CT Aortic enhancement in arterial phase is 280 HU or more Liver parenchyma enhancement in portal venous phase is 50 HU or more Coronary CT CT value of the coronary artery (LMT, RCA) after administration of Iopamiron is 325 HU or more
Key secondary outcomes	Correlation between the contrast enhancement (HU) and visual assessment Correlation between the contrast enhancement of liver(HU) and liver function Adverse effects

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	85 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patients who undergo either abdominal CT or coronary CT using Iopamiron Injection 300 or 370 (intravenous injection) (2) Either outpatients or inpatients (3) Either male or female (4) Those between the age of 20 years<= and <85 years (5) Those having a clear consciousness
Key exclusion criteria	(Exclusion criteria both abdominal and coronary CT) (1) With a past history of anaphylaxis to iodine and iodined contrast media (2) Serious thyroid disease (3) Women during pregnancy or lactation (4) eGFR less than 45mL/min (5) Patient who the doctor in charge judges are ineligible for the study (Exclusion criteria in the case of abdominal CT) (6) Those who underwent liver invasive therapy(ope/RFA/TAE etc.) within 3 months (Exclusion criteria in the case of coronary CT) (7) Severe cardiac arrest (8) Severe valve disease (9) Patient who underwent CABG surgery
Target sample size	2800

Research contact person
Name of lead principal investigator	Yasuyuki Yamashita
Organization	Kumamoto University
Division name	Department of Radiology
Address	1-1-1, Honjo, Tyuo-ku, Kumamoto
TEL	096-373-5261
Email	yama@kumamoto-u.ac.jp

Public contact
Name of contact person	Daisuke Utsunomiya
Organization	Kumamoto University
Division name	Department of Radiology
Address	1-1-1, Honjo, Kumamoto
TEL	0963735261
Homepage URL
Email	utsunomi@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University, Department of Radiology
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)

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	2012 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 09 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	nothing

Management information
Registered date	2012 Year 06 Month 20 Day
Last modified on	2017 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009686