臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 08, 2022
Last modified on	April. 24, 2024
Trial ID	jRCT1032220325

Scientific Title	Assessment of AI Breast (Anatomical Intelligence for Breast) Accuracy and Reproducibility
Public Title	Assessment of AI Breast Accuracy and Reproducibility

Contact for Scientific Queries	Name	Sakakibara Junta
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba
	Telephone	+81-43-222-7171
	E-mail	sakakibara-junta@chiba-u.jp
Contact for Public Queries	Name	Sakakibara Junta
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba
	Telephone	+81-43-222-7171
	E-mail	sakakibara-junta@chiba-u.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Sept. 08, 2022
Actual date of first enrollment		May. 15, 2023
Target sample size		15
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Breast cancer pathologically diagnosed by tissue biopsy. 20 years old or above(Female). Subjects has or will be undergoing MR or CT exam of the breast. Subjects who have a breast lesion visible under ultrasound.
	Exclusion Criteria	Subjects that do not have lesions visible under either ultrasound, CT or MR during the initial examination. Subjects with an implemented pacemaker. Breast cancer patients receiving or will receive preoperative medication.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Breast Cancer
Intervention(s)		After observing and recording the breast cancer lesion by ultrasonography, the localization of the lesion (clock board display) is recorded by the Auto Annotate function of AI Breast. We will compare the distance between nipple and tumors calculated from CT / MR images, the distance in the X / Y axis direction, and the tumor localization (conversion from polar coordinates to Cartesian coordinates) acquired by the Auto Annotate function. Inaddition, the maximum major axis of the coronal section image reconstructed from the volume data of the ultrasonography and the coronal section image of the CT / MR image is compared.We will also compare the reproducibility of the AI Breast function.
Health Condition(s) Keyword		Breast Cancer, Breast Tumor
Intervention(s) Keyword		Ultrasonic Diagnosis
Health Condition(s) Code		D001943
Intervention(s) Code		D014463
Primary Outcome(s)		Comparison of nipple-to-tumor distance calculated from CT / MR images and AI Breast.
Secondary Outcome(s)		Comparison of nipple-to-tumor distance in the X / Y axis direction calculated from CT / MR images and AI Breast. Comparison of maximum major axis of lesion site in coronal section calculated from CT / MR image and AI Breast. Comparison of nipple-to-tumor distance calculated from the AI Breast of the initial and follow-up tests.

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Clinical Research Initiation Fund (of Chiba University Hospital)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1,Inohana,Chuo-ku,Chiba-city,Chiba,Japan, Chiba, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	April. 24, 2024	(this page)	Changes
4	April. 04, 2024	Detail	Changes
3	April. 03, 2024	Detail	Changes
2	April. 11, 2023	Detail	Changes
1	Sept. 08, 2022	Detail

List of change history