UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005504 |
|---|---|
| Receipt number | 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 11:51:22 |
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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
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
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006526
