UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042373 |
|---|---|
| Receipt number | R000048292 |
| Scientific Title | An interventional study aiming at the development of a non-contrast enhanced MRI test method for the testis in healthy adult subjects |
| Date of disclosure of the study information | 2020/11/06 |
| Last modified on | 2023/10/20 09:16:03 |
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Basic information
Public title
A clinical study for the development of Magnetic Resonance Imaging (MRI) of the testis in healthy adult subjects
Acronym
An MRI research of the testis
Scientific Title
An interventional study aiming at the development of a non-contrast enhanced MRI test method for the testis in healthy adult subjects
Scientific Title:Acronym
An interventional study aiming at the development of a non-contrast enhanced MRI test method for the testis
Region
| Japan |
Condition
Condition
Male infertility
Classification by specialty
| Urology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to develop an MRI test method to non-invasively determine a testicular region where spermatogenesis is highly activated.
Basic objectives2
Others
Basic objectives -Others
A study on the development of MRI examination method
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The feasibility of magnetic resonance imaging (MRI) test of the testis that is capable of visualizing a testicular region where spermatogenesis is highly activated. To accomplish a high quality MRI test, a circular radiofrequency coil will be used and the testis will be immobilized during the MRI test by using a special underwear.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-contrast-enhanced magnetic resonance imaging test
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1) Male individuals aged more than 20 years but no more than 50 years
2) Those whose spouse or female partner gave birth more than one child by normal pregnancy or those whose sperm test result is normal i.e. sperm count is more than 15 million per milliliter and motility rate is more than 40% according to WHO criteria version 5.
3) Those who do not have a congenital anomaly in the urogenital organs and who do not have a medical history and/or treatment history of any urogenital disorder and any trauma in the urogenital organs.
4) Those who do not have a medical history and/or treatment history of varicocele.
5) Those who do not have medical history and treatment history of malignant tumors, endocrinology disorders, and autoimmune diseases.
6) Those who do not have a medication history of hormonal agents
Key exclusion criteria
1) Individuals who may consent for participation in this study under duress.
2) Those who have a ferromagnetic metal item in their body.
3) Those who have claustrophobia
4) Those who have tattoos
5) Those who have neurological disorders
6) Those who have cognitive impairment
7) Those who have psychological disorders including depression, schizophrenia, and bipolar disorder.
8) Those whom physicians have judged inappropriate for participation in this research study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Cancer Center Exploratory Oncology Research & Clinical Trial Center
Division name
Division of Functional Imaging
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa, Chiba
TEL
04-7134-6832
fidadmin@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Cancer Center Exploratory Oncology Research & Clinical Trial Center
Division name
Division of Functional Imaging
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa, Chiba
TEL
04-7134-6832
Homepage URL
https://www.ncc.go.jp/jp/about/research_promotion/study/list/index.html
masyamag@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Cancer Center Hospital East, Department of Diagnostic Radiology
University of Tsukuba, Faculty of Medicine, Department of Urology
MR Technology, Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
Tsukiji 5-1-1, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.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 | 11 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048292
