UMIN-CTR Clinical Trial

Basic information
Public title	Investigation on a novel MR scan method, MR fingerprinting to elucidate tissue properties
Acronym	Investigation on MR fingerprinting
Scientific Title	Investigation on a novel MR scan method, MR fingerprinting to elucidate tissue properties
Scientific Title:Acronym	Investigation on MR fingerprinting
Region	Japan Europe

Condition
Condition	Brain: neurodegenerative disorders, tumors and controls. Breast, abdomen, pelvis: tumors and controls.
Classification by specialty	Hepato-biliary-pancreatic medicine Neurology Breast surgery Obsterics and gynecology Psychiatry Urology Radiology Neurosurgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To scan normal controls and patients with disorders in the brain, breast, abdomen and pelvis using MR fingerprinting and evaluate stability of measured values. If capable, they are analyzed in correlation to pathological conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stability of quantitative values measured using MR fingerprinting.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects aged 20 - 90 years old, who will take MR exams in the hospital.
Key exclusion criteria	Subjects contra-indicated to the MRI scan.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Kaori Middle name Last name Togashi
Organization	Kyoto University
Division name	Diagnostic Imaging and Nuclear Medicine, Graduate School of Medicine
Zip code	606-8507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	075-751-3760
Email	ktogashi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Tomohisa Middle name Last name Okada
Organization	Kyoto University
Division name	Human Brain Research Center, Graduate School of Medicine
Zip code	606-8507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	075-751-3602
Homepage URL
Email	tomokada@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	University of Essen, Germany.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committee
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	京都大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/32248322/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/32248322/
Number of participants that the trial has enrolled	41
Results	Measurement repeatability and coefficient of variation was confirmed using a phantom and subjects of small size.
Results date posted	2021 Year 09 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Young healthy subjects.
Participant flow	Limited enrollment.
Adverse events	None.
Outcome measures	Coefficients of variation of test-retest measurements.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 05 Day
Date of IRB	2018 Year 04 Month 12 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2020 Year 04 Month 11 Day
Date of closure to data entry	2020 Year 04 Month 11 Day
Date trial data considered complete	2020 Year 04 Month 11 Day
Date analysis concluded	2020 Year 04 Month 11 Day

Other
Other related information	MR fingerprinting scan will be conducted at the same level, and mead and SD values will be evaluated.

Management information
Registered date	2018 Year 03 Month 05 Day
Last modified on	2021 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036071