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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010692
Receipt No. R000012441
Scientific Title the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Date of disclosure of the study information 2013/05/13
Last modified on 2016/12/01

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Basic information
Public title the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Acronym the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Scientific Title the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Scientific Title:Acronym the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a new diagnostic method of cancer to explore the potential of the diffusion and perfusion MRI parameters obtained from IVIM MRI
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 Patients who meet all of the following conditions.
1. Breast cancer is suspected clinically.
2. A MRI scan was ordered for staging.
3. Written informed consent was obtained.
Key exclusion criteria Patients who meet at least one of the following conditions.
1. Communication difficulty.
2. General conditions are extremely poor.
3. Informed consent not given.
Target sample size 150

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

Public contact
Name of contact person
1st name
Middle name
Last name Mami Iima
Organization Kyoto University 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 University Hospital
Institute
Department

Funding Source
Organization None
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
2013 Year 05 Month 13 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 15 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 the new data

Management information
Registered date
2013 Year 05 Month 10 Day
Last modified on
2016 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012441

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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