UMIN-CTR Clinical Trial

Public title

Investigation into Optimal Administration of Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for Hepatocellular Carcinoma

Acronym

Investigation into Optimal Administration of Ga-EOB-DTPA and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for HCC

Scientific Title

Investigation into Optimal Administration of Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for Hepatocellular Carcinoma

Scientific Title:Acronym

Investigation into Optimal Administration of Ga-EOB-DTPA and Appropriate Timing of Arterial Phase of Enhanced Liver Magnetic Resonance Imaging for HCC

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine	Hepato-biliary-pancreatic surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Investigation into optimal arterial phase of dynamic liver MRI with Gd-EOB-DTPA

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

We make time intensity curves of tumor, parenchyma of liver and aorta in each way of administration and also investigate these data.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Duration:the day of MRI examination.
All fluid (EOB + saline):0.5ml per 1kg body weight, using EOB undiluted.

Interventions/Control_2

Duration:the day of MRI examination.
All fluid (EOB + saline):0.5ml per 1kg body weight, using EOB with doubled dilution.

Interventions/Control_3

Duration:the day of MRI examination.
All fluid (EOB + saline):1ml per 1kg body weight, using EOB undiluted.

Interventions/Control_4

Duration:the day of MRI examination.
All fluid (EOB + saline):1ml per 1kg body weight, using EOB with doubled dilution.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who were diagnosed as hepatocellular carcinoma by contrast enhanced CT and was scheduled for surgical resection.
2) Patients who can undergo EOB-MRI within one month from contrast enhanced CT.
3) Patients who announced voluntary consent through their writing after a full explanation of the study and a enough understanding.
4) Patients over 20 years old at the time of obtaining informed consent.

Key exclusion criteria

1) Patients with lesions that are received prior RFA or TAE treatment.
2) Patients with a history of hypersensitivity to gadolinium-based contrast agent or this test drug.
3) Patients who have asthma.
4) Patients with severe kidney disease. (eGFR<30mL/min/1.73square meter or serum Cr>1.5mg/dl)
5) Patients during pregnancy or potential pregnancy.
6) Patients who are lactating women.
7) Patients who have advanced nyctophobia cabin.

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Masaaki Akahane

Organization

University of Tokyo

Division name

Department of Radiology

Zip code

Address

7-3-1 Hongo Bunkyo-ku Tokyo, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

University of Tokyo

Division name

Department of Radiology

Zip code

Address

7-3-1 Hongo Bunkyo-ku Tokyo, Japan

TEL

Homepage URL

Email

Institute

Department of Radiology, Graduate School of Medicine, University of Tokyo

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

2010

Year

08

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Terminated

Date of protocol fixation

2010

Year

07

Month

02

Day

Date of IRB

Anticipated trial start date

2010

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

08

Month

26

Day

Last modified on

2014

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004691