UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026386 |
|---|---|
| Receipt number | 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 | 2022/09/12 14:07:18 |
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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 | 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
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
i-waki1031@sagara.or.jp
Sponsor or person
Institute
Sagara hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030317
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
