UMIN-CTR Clinical Trial

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

hepatocellular carcinoma
coronary infarction

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO

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

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

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 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

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

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

Institute

Kumamoto University, Department of Radiology

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

Date of disclosure of the study information

2012

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related information

nothing

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