UMIN-CTR Clinical Trial

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 Mitsuhiro Middle name Last name Tozaki
Organization	Sagara hospital
Division name	Radiology
Zip code	892-0833
Address	3-31 Shinyashiki-cho, Kagoshima City
TEL	099-224-1800
Email	tozaki@sagara.or.jp

Public contact
Name of contact person	1st name Ikumi Middle name Last name Waki
Organization	Hakuaikai Social Medical Corporation Sagara Hospital
Division name	Clinical Research Center
Zip code	892-0833
Address	3-31 Shinyashiki-cho, Kagoshima City
TEL	099-224-1800
Homepage URL
Email	i-waki1031@sagara.or.jp

Sponsor
Institute	Sagara hospital
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	Social medical corporation Hakuaikai Sagara Hospital Institutional Review Board
Address	3-31 Shinyashiki-cho, Kagoshima City
Tel	099-224-1823
Email	i-waki1031@sagara.or.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	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	Completed
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 01 Month 17 Day
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	2022 Year 09 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030317