Breast diseases
Conditions
Interventions
Sponsors
Department of Radiology, Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) The subject presents with suspicious breast clinical symptoms and / or previous breast findings on other breast imaging; 2) The subject is undergoing bi-lateral contrast-enhanced MRI as part of routine care; 3) The subject is willing to have all imaging procedures (MRI, CESM) completed within 1 week. For those premenopausal women, both exams should be completed at the same week of menstrual cycle; 4) If of child-bearing potential, the subject should be confirmed non-pregnant by negative urine pregnancy test and be non-lactating; 5) The patient who fully understood the ICF and has signed the ICF.
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy to iodinated contrast agents or a history of multiple allergies or asthma; 2) Known or suspected renal insufficiency, as evidence by either medical history or verbal patient disclosure; 3) Have breast implants in one or both breasts; 4) Have a history of breast surgery, radiotherapy, chemotherapy or endotherapy; 5) Patients whose results were not confirmed by the gold standard; 6) Ineligible patients according to the researches' evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve;Accuracy;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value;Negative predictive value; | — |
Countries
China
Contacts
Public ContactYajia Gu
Department of Radiology, Fudan University Shanghai Cancer Center
Outcome results
None listed