UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012023
Receipt No. R000014047
Scientific Title Influence of menstrual cycle and aging on breast MR imaging
Date of disclosure of the study information 2013/10/11
Last modified on 2016/10/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Influence of menstrual cycle and aging on breast MR imaging
Acronym Influence of menstrual cycle and aging on breast MR imaging
Scientific Title Influence of menstrual cycle and aging on breast MR imaging
Scientific Title:Acronym Influence of menstrual cycle and aging on breast MR imaging
Region
Japan

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

Objectives
Narrative objectives1 To investigate the relationship between background parenchymal enhancement (BPE) and menstrual cycle/ age on breast MRI in Japanese women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between background parenchymal enhancement (BPE) and menstrual cycle/ age.
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
70 years-old >
Gender Female
Key inclusion criteria Women scheduled to undergo contrast-enhanced dynamic MRI of breasts.
Key exclusion criteria Patients with known hypersensitivity to the gadolinium-based contrast agents.
Patients with the past history of breast cancer
Patients who are under drug therapy for breast cancer.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Honda
Organization Kyusyu University
Division name Department of Clinical Radiology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Hukuoka ,812-8582, JAPAN
TEL 092-642-5695
Email honda@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidetake Yabuuchi
Organization Kyusyu University
Division name Department of Health Sciences
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Hukuoka ,812-8582, JAPAN
TEL 092-642-6727
Homepage URL
Email h-yabu@med.kyushu-u.ac.jp

Sponsor
Institute Kyusyu University
Institute
Department

Funding Source
Organization Bayer Yakuhin
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 10 Month 11 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 06 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information Patients are registered non-selectively.
Patient background and MR imaging information are recorded, and statistical analysis of the data is carried out.

Management information
Registered date
2013 Year 10 Month 11 Day
Last modified on
2016 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.