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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014439
Receipt No. R000016800
Scientific Title Investigation on radiotherapy treatment effect using perfusion and diffusion-weighted MR imaging
Date of disclosure of the study information 2014/07/03
Last modified on 2016/03/30

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Basic information
Public title Investigation on radiotherapy treatment effect using perfusion and diffusion-weighted MR imaging
Acronym Investigation on a non-invasive evaluation method using perfusion and diffusion-weighted MR imaging
Scientific Title Investigation on radiotherapy treatment effect using perfusion and diffusion-weighted MR imaging
Scientific Title:Acronym Investigation on a non-invasive evaluation method using perfusion and diffusion-weighted MR imaging
Region
Japan

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

Objectives
Narrative objectives1 to develop a new diagnostic method to explore the potential of the diffusion and perfusion MRI parameters obtained IVIM MRI for radiotherapy treatment effect
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic performance
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients who will undergo radiotherapy and be scanned with MRI using multi b value
Key exclusion criteria informed consent not given
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaori Togashi
Organization Kyoto Univerisity Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3760
Email nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mami Iima
Organization Kyoto Univerisity Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3760
Homepage URL
Email mamiiima@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Univerisity Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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
2014 Year 07 Month 03 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 Terminated
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study acquiring new data

Management information
Registered date
2014 Year 07 Month 01 Day
Last modified on
2016 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016800

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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