UMIN-CTR Clinical Trial

Basic information
Public title	Development of automatic 3-dimensional MRI analysis software for knee joint
Acronym	Development of automatic 3-dimensional MRI analysis software for knee joint
Scientific Title	Development of automatic 3-dimensional MRI analysis software for knee joint
Scientific Title:Acronym	Development of automatic 3-dimensional MRI analysis software for knee joint
Region	Japan

Condition
Condition	osteoarthritis of the knee, anterior cruciate ligament injury, meniscus injury, cartilage injury, the knee of healthy volunteer
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Construct of optimized MRI 3-dimensional image for cartilage and meniscus of the knee by VINCENT imaging system.
Basic objectives2	Others
Basic objectives -Others	Development and validation of the automatic quantification algorithm of the volume in this system.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assess the reproducibility and valiation between 3-demensional MRI images and their value of the volume and area of meniscus and cartilage.
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Healthy volunteers with no history of knee disease or injury are included. Knee 3.0 T MRI images collected from 2006 will be analyzed. Image and value of the volume and area among each group will be compared. Data of the MRI within the same day will be examined.
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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy volunteer with no history of knee disease or injury.
Key exclusion criteria	Contraindication for MRI imaging
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Ichiro Middle name Last name Sekiya
Organization	Tokyo Medical and Dental University
Division name	Center of Stem Cell and Regenerative Medicine
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku
TEL	0358034017
Email	sekiya.arm@tmd.ac.jp

Public contact
1st name of contact person	1st name Office administrator Middle name Last name Office administrator
Organization	Tokyo Medical and Dental University
Division name	Center of Stem Cell and Regenerative Medicine
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku
TEL	03-5803-4017
Homepage URL
Email	saisei01.arm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japanese Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB for TMDU
Address	1-5-45 Yushima, Bunkyo-ku
Tel	0358036111
Email	info.bec@tmd.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	2018 Year 05 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	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 27 Day
Date of IRB	2015 Year 09 Month 02 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2022 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	2018 Year 03 Month 27 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036437