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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005504
Receipt No. R000006526
Scientific Title Basic research and development of cancer screening system employed Non-contrast MR Imaging with Diffusion-weighted Whole-body MR imaging with background body signal suppression (DWIBS)
Date of disclosure of the study information 2011/05/01
Last modified on 2013/05/30

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Basic information
Public title Basic research and development of cancer screening system employed Non-contrast MR Imaging with Diffusion-weighted Whole-body MR imaging with background body signal suppression (DWIBS)
Acronym Basic research and development of cancer screening system employed Non-contrast MR Imaging with DWIBS
Scientific Title Basic research and development of cancer screening system employed Non-contrast MR Imaging with Diffusion-weighted Whole-body MR imaging with background body signal suppression (DWIBS)
Scientific Title:Acronym Basic research and development of cancer screening system employed Non-contrast MR Imaging with DWIBS
Region
Japan

Condition
Condition cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is basic research and development of whole body cancer screening system employed Non-contrast MR Imaging with DWIBS. For the first step, Evaluation of the trunk is analyzed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detectability (sensitivity and specificity) of cancers by non-contrast MRI screening
Key secondary outcomes Detectability (sensitivity and specificity) of cancers by non-contrast MRI compared with PET/CT

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 A period: From May, 2011 to March, 2013
Image acquisition: DWI, T2-weighted image, T1-weighted image
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 40 years of age or older who provided consent to participate in the study and who underwent PET/CT
Key exclusion criteria Cancer diagnosis within the past year and being treated or under observation, or those who received a detailed examination or were under observation because of suspected cancer or precancerous lesion.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiko Suzuki
Organization National Cancer Center
Division name Research Center for Cancer Prevention and Screening
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Cancer Center
Division name Research Center for Cancer Prevention and Screening
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding 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
2011 Year 05 Month 01 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
2011 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 25 Day
Last modified on
2013 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006526

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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