Project HUMam
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCTs042230020
- Lead Sponsor
- ematsu Takayoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion 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.
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Evaluation of overall image quality of conventional ultrasound and hybrid breast ultrasound/mammography by two outsider radiologists independently<br>(2) Evaluation of overall image quality of conventional mammography and hybrid breast ultrasound/mammography by two outsider radiologists independently<br>(3) Patients' acceptability of hybrid breast ultrasound/mammography examination
- Secondary Outcome Measures
Name Time Method (1) Comparison of conventional ultrasound and hybrid breast ultrasound/mammography for evaluating accuracy of breast cancer<br>(2) Comparison of conventional mammography and hybrid breast ultrasound/mammography for evaluating accuracy of breast cancer<br>(3) Comparison of tomosynthesis and hybrid breast ultrasound/mammography for evaluating accuracy of breast cancer<br>(4) Comparison between certificated doctors and non-certificated doctors about diagnostic accuracy of breast cancer