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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name