臨床研究等提出・公開システム

Date of registration	Aug. 28, 2026
Last modified on	Aug. 28, 2026
Trial ID	jRCT1030260443

Scientific Title	Development and Evaluation of an Automated Quantitative Analysis Program for Local Signal Intensity Changes in Brain MRI
Public Title	Development and Evaluation of an Automated Quantitative Analysis Program for Brain MRI

Contact for Scientific Queries	Name	Ikeda Hitoshi
	Affiliation	Splink,Inc.
	Address	4F WAW Akasaka 35th Kowa Bldg., 1-14-14 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-3-3589-2010
	E-mail	hitoshi.ikeda@splinkns.com
Contact for Public Queries	Name	Suzui Eri
	Affiliation	Splink,Inc.
	Address	4F WAW Akasaka 35th Kowa Bldg., 1-14-14 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-3-3589-2010
	E-mail	eri.suzui@splinkns.com

Recruitment status	Pending

Anticipated date of first enrollment		Aug. 28, 2026
Target sample size		788
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1 Aged 20 years or older at the time of data (or image) acquisition 2 Subjects with available age, sex, and brain MRI data, with mandatory FLAIR sequence (3DT1, T2*, and SWI are optional) 3 Patients who have completed diagnosis and imaging at a medical facility, or are scheduled to undergo the procedures during the study period
	Exclusion Criteria	1. Individuals who decline participation in this study (those who opt out of study participation, or who refuse or withdraw consent). 2. Individuals with obvious poor image quality, such as severe artifacts, who are deemed unsuitable for analysis.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Without restriction to specific diseases
Primary Outcome(s)		Evaluation of the correlation between output values from existing standard neuroimaging software and total FLAIR white matter hyperintensity volume output by this automated quantitative analysis program
Secondary Outcome(s)		1 Evaluation of the relationship between program-derived anatomical parcellations of FLAIR WMHs (deep and periventricular white matter) and existing clinical labels (e.g., Fazekas scale) 2 Exploratory evaluation of the utility of 3D T1-based regional brain volumes/atrophy and other imaging features (spatial/morphological characteristics of FLAIR WMHs and T2*/SWI hypointensities) for diagnostic support and predictive modeling in neurological disorders

Primary Sponsor	Splink,Inc.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Shiba Palace Clinic Ethics Committee
Address	6F Daiwa A Hamamatsucho Bldg., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5408-1559
E-Mail	rinri@s-palace-clinic.com
Approval Status	Approval
Date of approval	July. 23, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none