臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 11, 2022
Last modified on	Aug. 11, 2022
Trial ID	jRCT1040220052

Scientific Title	Observational study to establish evaluation method for vascular abnormalities using deep learning
Public Title	Radiological study for vascular anomalies using AI

Contact for Scientific Queries	Name	Michio Ozeki
	Affiliation	Gifu University Hospital
	Address	1-1, yanagito, Gifu-shi, Gifu
	Telephone	+81-58-230-6000
	E-mail	michioo@gifu-u.ac.jp
Contact for Public Queries	Name	Michio Ozeki
	Affiliation	Gifu University Hospital
	Address	1-1, yanagito, Gifu-shi, Gifu
	Telephone	+81-58-230-6000
	E-mail	michioo@gifu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 11, 2022
Actual date of first enrollment
Target sample size		20
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1, A multicenter phase III investigator-initiated clinical trial (NPC-12T-LM study) conducted from 2017 to 2019 to investigate the efficacy and safety of NPC-12T (sirolimus) for intractable lymphatic disease, Multi-center, open-label, uncontrolled study to investigate the safety and efficacy of sirolimus for refractory vascular and lymphatic diseases (SRL-CVA-01 study, jRCTs031180290) started in 2017, and Conducted from 2020 to 2022, a multicenter phase III investigator-initiated clinical trial (NPC -12T-CVA) 2) Patients with evaluable MRI images 3) Patients who agreed to participate in this study
	Exclusion Criteria	1) Patients with other than obvious vascular abnormalities 2) Patients with clearly different lesions and image artifacts such as bleeding and inflammation that are difficult to evaluate 3) Other patients who are judged to be inappropriate by the principal investigator or co-investigator
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Vascular anomalies
Intervention(s)
Health Condition(s) Keyword		hemangioma, vascular anomalies
Intervention(s) Keyword
Health Condition(s) Code		D009383
Intervention(s) Code
Primary Outcome(s)		Correlation coefficient between "lesion volume of vascular abnormalities measured by deep learning" and "lesion volume independently measured by two radiologists"
Secondary Outcome(s)		Correlation coefficient (ICC(2,1)) of analysis results of area and volume measured independently by two radiologists and a trained doctor Differences in AI segmentation and correlation coefficients with different MRI images (fat-suppressed T2-weighted images, T1-weighted images, contrast-enhanced T1-weighted images, etc.)

Primary Sponsor	Michio Ozeki

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	AMED
Secondary Sponsor	Applicable

Name of Certified Review Board	Gifu University Medical Research Ethics Review Committee
Address	1-1, yanagito, Gifu-shi, Gifu, Gifu
Telephone	+81-582306000
E-Mail	rinri-shinsei@gifu-u.ac.jp
Approval Status	Approval
Date of approval	June. 06, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none