UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010692
Receipt number 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 2020/11/14 09:39:23

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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 Kaori
Middle name
Last name Togashi

Organization

Kyoto University Hospital

Division name

Department of Diagnostic Radiology

Zip code

6068507

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 Mami
Middle name
Last name Iima

Organization

Kyoto University Hospital

Division name

Department of Diagnostic Radiology

Zip code

6068507

Address

54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto

TEL

075-751-3760

Homepage URL


Email

mamiiima@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



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

Kyoto University Graduate School of Medicine, Ethics Comittee

Address

54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto

Tel

075-753-9470

Email

ethcom@kuhp.kyoto-u.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



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

Completed

Date of protocol fixation

2013 Year 05 Month 15 Day

Date of IRB

2013 Year 05 Month 27 Day

Anticipated trial start date

2013 Year 05 Month 29 Day

Last follow-up date

2015 Year 03 Month 31 Day

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

2020 Year 11 Month 14 Day



Link to view the page

Value
https://center6.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