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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026386
Receipt No. R000030317
Scientific Title Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI
Date of disclosure of the study information 2017/03/06
Last modified on 2018/09/22

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Basic information
Public title Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI
Acronym Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI
Scientific Title Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI
Scientific Title:Acronym Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI
Region
Japan

Condition
Condition Patients who are scheduled to undergo breast dynamic MRI for breast cancer or suspected breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of background parenchymal enhancement on contrast during the early phase of breast dynamic MRI using background
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To determine the effect of background parenchymal enhancement on contrast during the early phase of breast dynamic MRI using background
: lesion-to-background contrast with gadobutrol will be compared with the large-scale data
Key secondary outcomes To characterize the TIC of gadobutrol-enhanced breast dynamic MRI : The TIC will be compared with previous reports and discussed

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 -Patients who are scheduled to undergo breast MRI for breast cancer or suspected breast cancer
-Patients aged 20 to less than 70 years
-Patients with information on menstrual cycles available, if premenopausal
-Both the inpatient and outpatient settings are acceptable
Key exclusion criteria -Patients with known hypersensitivity to gadolinium-based contrast agents
-Patients with renal impairment (e-GFR : less than 30mL/min/1.73m2)
-Pregnant, Parturient or breastfeeding women
-Patients who experienced breast cancer in the past, with invasive treatment
-Patients receiving drug therapy for breast cancer
-Patients who are inappropriate for enrolment for any other reason in the opinion of the investigator
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Tozaki
Organization Sagara hospital breast center
Division name Radiology
Zip code
Address 26-13 Shinyashiki-cho, Kagoshima City
TEL 099-239-5255
Email tozaki@sagara.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimi Kanemitsu/Misae Yamada
Organization Kondo photo process Co.,Ltd.
Division name Medical division
Zip code
Address 17-25 Shimizudani-cho, tennoji-ku Osaka-shi
TEL 06-6761-9191
Homepage URL
Email ko-120@rinsho-kenkyu.org

Sponsor
Institute Sagara hospital breast center
Institute
Department

Funding Source
Organization Bayer Yakuhin
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 相良病院(鹿児島県)、東京医科歯科大学(東京都)、京都府立医科大学(京都府)、九州大学(福岡県)、ブレストピア宮崎病院(宮崎県)/ Sagara hospital (Kagoshima Pref.), Tokyo medical and dental Univ. (Tokyo), Kyoto prefectural University of medicine (Kyoto), Kyushu Univ. (Fukuoka Pref.),Breastopia Miyazaki hospital (Miyazaki Pref.)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 06 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
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 01 Month 31 Day
Date analysis concluded
2020 Year 01 Month 31 Day

Other
Other related information The purpose of this study is to evaluate major evaluation items descriptively, to compare them with past study, and does not set statistical case based on main evaluation item

Management information
Registered date
2017 Year 03 Month 03 Day
Last modified on
2018 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030317

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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