UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032322
Receipt number 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 2021/10/21 13:58:52

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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

Obstetrics 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 or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



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

2021 Year 10 Month 21 Day



Link to view the page

Value
https://center6.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