UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038516
Receipt No. R000043892
Scientific Title Prospective observational study on image quality and diagnostic ability evaluation by glucagon administration during prostate MRI scan
Date of disclosure of the study information 2020/04/01
Last modified on 2019/11/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective observational study on image quality and diagnostic ability evaluation by glucagon administration during prostate MRI scan
Acronym Glucagon administration test at prostate MRI scan
Scientific Title Prospective observational study on image quality and diagnostic ability evaluation by glucagon administration during prostate MRI scan
Scientific Title:Acronym Glucagon administration test at prostate MRI scan
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to evaluate objectively and subjectively whether glucagon used as a pre-medication during prostate MRI imaging contributes to improving image quality and diagnostic ability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes It is an objective index (quantitative) for image quality evaluation, and performs SNR (signal-to-noise ratio) evaluation.

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Glucagon administration
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
40 years-old <
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria (1) Situation where prostate cancer or prostate cancer is suspected
(2) Regardless of stage or stage when prostate cancer is diagnosed
(3) Up to 80 years old
(4) Male
Key exclusion criteria Excluded if consent to this study is not obtained.
Target sample size 65

Research contact person
Name of lead principal investigator
1st name Naoko
Middle name
Last name Mori
Organization Tohoku University
Division name Diagnostic Radiology
Zip code 9808574
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL 0227177312
Email naokomori7127@gmail.com

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Mori
Organization Tohoku University
Division name Diagnostic Radiology
Zip code 9808574
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL 0227177312
Homepage URL
Email naokomori7127@gmail.com

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
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 Tohoku University
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 07 Day
Last modified on
2019 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.