UMIN-CTR Clinical Trial

Public title

Japanese multi institutional study of Primovist-enhanced MRI for non-invasive diagnosis of HCC (JAMP-HCC study)

Acronym

Japanese multi institutional study of Primovist-enhanced MRI for non-invasive diagnosis of HCC (JAMP-HCC study)

Scientific Title

Japanese multi institutional study of Primovist-enhanced MRI for non-invasive diagnosis of HCC (JAMP-HCC study)

Scientific Title:Acronym

Japanese multi institutional study of Primovist-enhanced MRI for non-invasive diagnosis of HCC (JAMP-HCC study)

Region

Japan

Condition

hepatic carcinoma

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the typical findings for diagnosis of hypervascular HCC using EOB-enhanced MRI.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Diagnosability (sensitivity, specificity, PPV, NPV, and positive/negative likelihood ratio) using typical findings of HCC by EOB-enhanced MRI (low signal intensity in the hepatocyte phase plus other findings) is compared to that of dynamic CT

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

Patients who suspected HCC are prospectively enrolled, and these patients will undergo contrast enhanced CT and EOB enhanced MRI (T1WI, T2WI, DWI, and enhanced T1WI).

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Step 1:
Patients with final pathological diagnosis of liver tumors (including those other than HCC) for which EOB-enhanced MRI was performed before pathological diagnosis

Inclusion criteria:
Patients who meet all of the following criteria are included.
1.Patients who have chronic hepatic disease
2.Patients who underwent EOB-enhanced MRI 3. Patients with final pathological diagnosis of liver tumors (including those other than HCC) 4. Patients who are 20 years or older

Step 2:
Patients with suspected HCC who are expected to undergo EOB-enhanced MRI
Inclusion criteria:
Patients who meet all of the following criteria are included.
1. Patients who have chronic hepatic disease
2.Patients who are expected to undergo EOB-enhanced MRI and dynamic CT scan
3. Both inpatients and outpatients
4. Patients who are 20 years or older
5. Patients with clear consciousness

Key exclusion criteria

Step 1:
Patients who meet any of the followingcriteria are not included in this study.
1. Patients who are judged to be inappropriate by the physician in charge
Step 2:
Patients who meet any of the following criteria are not included in this study.
1. Patients who are contraindicated or relatively contraindicated for iodine contrast agents and gadolinium contrast agents
2. Child-Pugh C
3. Patients with diffuse liver tumors
4. Patients who are judged to be inappropriate by the physician in charge (patients in terminal care, etc.)

Target sample size

450

Name of lead principal investigator

1st name
Middle name
Last name	Tomoaki Ichikawa

Organization

University of Yamanashi hospital

Division name

Department of Radiology

Zip code

Address

1110, Shimogato, Chuo, Yamanashi, 409-3898

TEL

055-273-1111

Email

ichikawa@yamanashi.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomoaki Ichikawa

Organization

University of Yamanashi hospital

Division name

Department of Radiology

Zip code

Address

1110, Shimogato, Chuo, Yamanashi, 409-3898

TEL

055-273-1111

Homepage URL

Email

ichikawa@yamanashi.ac.jp

Institute

Department of Radiology doctors' office, University of Yamanashi hospital

Institute

Department

Personal name

Organization

Bayer Yakuhin, Ltd

Organization

Division

Category of Funding Organization

Profit organization

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

2013

Year

09

Month

14

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

Preinitiation

Date of protocol fixation

2013

Year

04

Month

22

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

15

Day

Last follow-up date

2016

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

13

Day

Last modified on

2013

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013684