UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008219 |
|---|---|
| Receipt number | 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 10:01:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
utsunomi@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University, Department of Radiology
Institute
Department
Personal name
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
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
Value
https://center6.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 |
