Assessment of AI Breast Accuracy and Reproducibility

JRCT ID: jRCT1032220325

Registered date:08/09/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 15/05/2023
• Target sample size: 15
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Comparison of nipple-to-tumor distance calculated from CT / MR images and AI Breast.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sakakibara Junta
• Source(s) of Monetary Support: Clinical Research Initiation Fund (of Chiba University Hospital)