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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008219
Receipt No. R000009686
Scientific Title 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
Date of disclosure of the study information 2012/07/01
Last modified on 2017/08/19

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Basic information
Public title 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
Acronym Iopamiron Abdominal and Cardiac CT enhancement study (IOPAC study)
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuyuki Yamashita
Organization Kumamoto University
Division name Department of Radiology
Zip code
Address 1-1-1, Honjo, Tyuo-ku, Kumamoto
TEL 096-373-5261
Email yama@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Utsunomiya
Organization Kumamoto University
Division name Department of Radiology
Zip code
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)

IRB Contact (For public release)
Organization
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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 04 Month 09 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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