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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032322
Receipt No. R000036846
Scientific Title Accuracy of T1 measurements for the uterus with B1 Correction
Date of disclosure of the study information 2018/04/20
Last modified on 2020/10/21

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Basic information
Public title Accuracy of T1 measurements for the uterus with B1 Correction
Acronym Accuracy of T1 measurements for the uterus with B1 Correction
Scientific Title Accuracy of T1 measurements for the uterus with B1 Correction
Scientific Title:Acronym Accuracy of T1 measurements for the uterus with B1 Correction
Region
Japan

Condition
Condition Uterine fibroids
Classification by specialty
Obsterics and gynecology Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate an accuracy of T1 measurements for uterine MR Imaging at 3 T using variable flip angle methods with B1 inhomogeneity correction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To assess T1 measurement errors for uterine MRI using variable flip angle methods with and without B1 inhomogeneity correction
Key secondary outcomes Correlation between inversion recovery(IR)methods and variable flip angle methods

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 T1 measurements using variable flip angle methods with B1 correction
Period:1 day
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
85 years-old >
Gender Female
Key inclusion criteria No history of surgery for pelvic diseases in the past

Completed obtaining informed consent for voluntary participation in this study
Key exclusion criteria History of surgery for pelvic diseases in the past

Subject determined inappropriate for voluntary by attending doctor

Pregnant or breast-feeding

Claustrophobia
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Shunta
Middle name
Last name Ishitoya
Organization Asahikawa Medical University
Division name Department of Radiology
Zip code 078-8510
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL 0166-68-2572
Email ishitoya@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name Sadahiro
Middle name
Last name Nakagawa
Organization Asahikawa Medical University Hospital
Division name Section of Radiological Technology
Zip code 078-8510
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL 0166-65-3430
Homepage URL
Email nakasada@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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 Asahikawa Medical University Research Support Section
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
Tel 0166-68-2297
Email rs-kk.g@asahikawa-med.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 旭川医科大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 20 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 63
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
2018 Year 04 Month 20 Day
Date of IRB
2018 Year 01 Month 21 Day
Anticipated trial start date
2018 Year 04 Month 23 Day
Last follow-up date
2019 Year 11 Month 15 Day
Date of closure to data entry
2019 Year 11 Month 30 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 19 Day
Last modified on
2020 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036846

Research Plan
Registered date File name
2019/10/21 研究実施計画書 2019 02 22.docx

Research case data specifications
Registered date File name
2019/10/21 201900928.xlsx

Research case data
Registered date File name
2019/10/21 20191015 uno.xlsx


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