Project HUMam

JRCT ID: jRCTs042230020

Registered date:01/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 01/08/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Ultrasound is performed during mammography compression.

Outcome(s)

Primary Outcome

(1) Evaluation of overall image quality of conventional ultrasound and hybrid breast ultrasound/mammography by two outsider radiologists independently
(2) Evaluation of overall image quality of conventional mammography and hybrid breast ultrasound/mammography by two outsider radiologists independently
(3) Patients' acceptability of hybrid breast ultrasound/mammography examination

Secondary Outcome

(1) Comparison of conventional ultrasound and hybrid breast ultrasound/mammography for evaluating accuracy of breast cancer
(2) Comparison of conventional mammography and hybrid breast ultrasound/mammography for evaluating accuracy of breast cancer
(3) Comparison of tomosynthesis and hybrid breast ultrasound/mammography for evaluating accuracy of breast cancer
(4) Comparison between certificated doctors and non-certificated doctors about diagnostic accuracy of breast cancer

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients must be scheduled for mammography/tomosynthesis, ultrasound, and MRI tests.
(2) Patients must be willing and able to provide a written informed consent.
(3) Patients must be women age 20 or older at the time of study entry.

Exclude criteria

(1) Patients who are pregnant or have pregnancy possibility.
(2) Patients who have metallic clips or foreign bodies, pacemakers, and so on.
(3) Patients who have any allergic diathesis including asthma and any known allergy to paramagnetic contrast agents.
(4) Patients who are judged to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Uematsu Takayoshi
• Source(s) of Monetary Support: FUJIFILM Corporation