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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021489
Receipt No. R000024748
Scientific Title The evaluation of ultra-fast dynamic study in clinical use
Date of disclosure of the study information 2016/03/20
Last modified on 2019/03/11

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Basic information
Public title The evaluation of ultra-fast dynamic study in clinical use
Acronym The evaluation of ultra-fast dynamic study in clinical use
Scientific Title The evaluation of ultra-fast dynamic study in clinical use
Scientific Title:Acronym The evaluation of ultra-fast dynamic study in clinical use
Region
Japan

Condition
Condition Tumors and inflammatory disease
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improvement in the distribution or vascularity of the disease using ultra-fast dynamic study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement in the evaluation of distribution or vascularity of the disease
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The patients who were planned the dynamic MRI study for evaluating the tumor extension or vascularity which was diagnosed on the previously-performed CT, US or angiography
Key exclusion criteria 1. Age under 20 y/o
2. Women in pregnancy or with suspected pregnancy.
3. A person with implants operating electrically, magnetically or mechanically
4. Claustophobia
5. A person who was judged to be inadequate for enrolling in this study by the investigator
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Shigeo
Middle name
Last name Okuda
Organization Keio University School of Medicine
Division name Diagnostic Radiology
Zip code 1608582
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 81-3-3353-1211
Email shige@keio.jp

Public contact
Name of contact person
1st name Shigeo
Middle name
Last name Okuda
Organization Keio University School of Medicine
Division name Diagnostic Radiology
Zip code 1608582
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 81-3-3353-1211
Homepage URL
Email shige@keio.jp

Sponsor
Institute Keio University School of Medicine
Department of Diagnostic Radiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.ac.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 慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 20 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 15 Day
Date of IRB
2016 Year 02 Month 15 Day
Anticipated trial start date
2016 Year 03 Month 22 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The dynamic studies performed with the ordinary method will be used for the historical control for evaluating the advantage of the ultra-fast method.

Historical control will include the conventional dynamic MR images of the patients with following conditions;
1) Whose dynamic MRI study was performed from January 2011 through December 2015 at Keio University Hospital.
2) Whose age, gender and size of a lesion are similar to the patient who are obtained images by using ultra-fast dynamic MRI in the current study.

Management information
Registered date
2016 Year 03 Month 16 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024748

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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