UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017013
Receipt number R000019731
Scientific Title Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT
Date of disclosure of the study information 2015/04/03
Last modified on 2019/04/18 22:32:47

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Basic information

Public title

Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT

Acronym

Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT

Scientific Title

Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT

Scientific Title:Acronym

Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the utility of a newly developed scan protocol of hepatic dynamic contrast-enhanced CT using low tube voltage and iterative reconstruction algorithm

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic performance of CT in detecting hepatocellular carcinomas

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Conventional scan protocol

Interventions/Control_2

Scan protocol with low tube voltage, reduced-dose of contrast material and iterative reconstruction algorithm

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with known or suspected liver tumor who are scheduled to undergo hepatic dynamic contrast-enhanced CT

Key exclusion criteria

(1) patients who participated in this study in the past
(2) patients with a contraindication for the use of contrast material
(3) informed consent cannot be obtained

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshifumi
Middle name
Last name Narumi

Organization

Osaka Medical College

Division name

Department of Radiology

Zip code

569-8686

Address

2-7, Daigakumachi, Takatsuki

TEL

072-683-1221

Email

narumi@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Nakamoto

Organization

Osaka Medical College

Division name

Department of Radiology

Zip code

569-8686

Address

2-7, Daigakumachi, Takatsuki

TEL

072-683-1221

Homepage URL


Email

rad117@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Toshiba Medical Systems Corporation
Eisai Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Medical College

Address

2-7, Daigakumachi, Takatsuki

Tel

072-683-1221

Email

rad117@osaka-med.ac.jp


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

2015 Year 04 Month 03 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

89

Results

Low tube voltage CT with AIDR 3D yielded a reduction in radiation dose and in
the amount of contrast material while maintaining diagnostic performance.

Results date posted

2019 Year 04 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2018 Year 08 Month 24 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 04 Month 03 Day

Date of IRB

2015 Year 01 Month 05 Day

Anticipated trial start date

2015 Year 05 Month 18 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 01 Day

Last modified on

2019 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019731


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name