Project AABUSS

JRCT ID: jRCTs042240132

Registered date:25/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 25/11/2024
• Target sample size: 3000
• Study type: Interventional
• Intervention(s): In addition to mammography (MG) and breast tomosynthesis (BT) as breast cancer screening methods, the implementation of an Automated Breast Ultrasound System (ABUS) is proposed.

Outcome(s)

• Primary Outcome: Assess the presence of specificity reduction due to the addition of ABUS when comparing the specificity of ABUS combined with MG/BT screening to MG/BT screening alone.

Secondary Outcome

- Compare the sensitivity of MG/BT screening with and without the addition of ABUS to evaluate the supplementary effect of ABUS.
- Assess the additive effect of ABUS when used in conjunction with MG/BT screening by comparing the breast cancer detection rates of MG/BT screening alone and in combination with ABUS.
- Comparison of recall rates and positive predictive values between MG/BT alone and the combined use of MG/BT and ABUS.
- Evaluate the non-inferiority of cancer detection rates using ABUS alone compared to MG/BT alone.
- For ABUS assessments, employ double reading and evaluate the concordance rate between the first and second readers' interpretations.

Key inclusion & exclusion criteria

• Age minimum: >= 35age old
• Age maximum: <= 74age old
• Gender: Female

Include criteria

(1)Women who plan to undergo breast cancer screening by their own decision using MG/BT and ABUS.
(2)Informed consent for participation in this study has been obtained through an electronic document, reflecting the voluntary agreement of the research subject themselves
(3)Women who are between the ages of 35 and under 75 at the time of consent acquisition.

Exclude criteria

(1)Women who are pregnant or may become pregnant.
(2)A woman with a history of breast cancer.
(3)Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigator.

Related Information

• Primary Sponsor: Uematsu Takayoshi
• Source(s) of Monetary Support: GE Healthcare Japan