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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011743
Receipt No. R000013684
Scientific Title Japanese multi institutional study of Primovist-enhanced MRI for non-invasive diagnosis of HCC (JAMP-HCC study)
Date of disclosure of the study information 2013/09/14
Last modified on 2013/09/13

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Basic information
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
Condition hepatic carcinoma
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Radiology doctors' office, University of Yamanashi hospital
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd
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
Address
Tel
Email

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
2013 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 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
Other related information

Management information
Registered date
2013 Year 09 Month 13 Day
Last modified on
2013 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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