UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038516 |
|---|---|
| Receipt number | 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 20:00:28 |
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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
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
naokomori7127@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043892
