Subjects with breast tumor
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Subjects with focal breast tumors - Subjects scheduled to undergo pathological examination - Subjects aged >=20 years old at the time of informed consent
Exclusion criteria
Exclusion criteria: - Items listed on the package insert (including absolute contraindications, careful administration, and precautions) to ensure safety - Items related to safety and ethics - Items related to surgery, procedures, and treatment influencing efficacy and safety assessment for DD-723 - Subjects who are pregnant, possibly pregnant, or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy rate of differential diagnosis Assessment by the blinded readers | — |
Secondary
| Measure | Time frame |
|---|---|
| Differential diagnostic performance, assessment of tumor extent diagnosis, evaluation of contrast effect Assessment by the blinded readers | — |