UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036475
Receipt number R000041566
Scientific Title Examination of whole body DWI using b = 1500 sec / mm2
Date of disclosure of the study information 2019/04/11
Last modified on 2020/10/12 08:05:33

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Basic information

Public title

Examination of whole body DWI using b = 1500 sec / mm2

Acronym

Examination of whole body DWI using b = 1500 sec / mm2

Scientific Title

Examination of whole body DWI using b = 1500 sec / mm2

Scientific Title:Acronym

Examination of whole body DWI using b = 1500 sec / mm2

Region

Japan


Condition

Condition

bone metastasis

Classification by specialty

Chest surgery Breast surgery Urology
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We will investigate whether it is possible to visualize normal bone even with a 3.0T MRI system by suppressing the background signal using ab value higher than b = 1000 sec / mm 2, which is usually used in body DWI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SNR and contrast ratio of spine and muscle, ADC value obtained by changing b value to 1000, 1200 and 1500 sec / mm 2

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

MRI without contrast agent

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy adults over 20 years old
The person who can hold the shooting position (supine position) for about 30 minutes

Key exclusion criteria

For claustrophobia
Possibility of pregnancy or being pregnant
If there is insertion of body metal

Target sample size

20


Research contact person

Name of lead principal investigator

1st name koutarou
Middle name
Last name yasumori

Organization

National Hospital Organization Kyushu Medical Center

Division name

Radiology department

Zip code

810-0065

Address

1-8-1 Jijihama, Chuo-ku, Fukuoka City, Fukuoka Prefecture

TEL

092-852-0700

Email

kawamata.keisuke.sj@mail.hosp.go.jp


Public contact

Name of contact person

1st name keisuke
Middle name
Last name kawamata

Organization

National Hospital Organization Kyushu Medical Center

Division name

Radiology department

Zip code

810-0065

Address

1-8-1 Jijihama, Chuo-ku, Fukuoka City, Fukuoka Prefecture

TEL

092-852-0700

Homepage URL


Email

kawamata.keisuke.sj@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Kyushu Medical Center

Institute

Department

Personal name



Funding Source

Organization

NO

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Kyushu Medical Center

Address

1-8-1 Jijihama, Chuo-ku, Fukuoka City, Fukuoka Prefecture

Tel

092-852-0700

Email

kawamata.keisuke.sj@mail.hosp.go.jp


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

2019 Year 04 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

15

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

Completed

Date of protocol fixation

2019 Year 04 Month 11 Day

Date of IRB

2019 Year 03 Month 27 Day

Anticipated trial start date

2019 Year 04 Month 11 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 04 Month 11 Day

Last modified on

2020 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name