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


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 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


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

Value
https://center6.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