C50.9
Conditions
Interventions
Group 1: Erstdiagnose Mammakarzinom mit auffälliger axillärer Sonographie
Sponsors
Uniklinik Aachen, Klinik für Gynäkologie und Geburtsmedizin
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. patients with histologically confirmed primary breast carcinoma (study part A) or histologically confirmed primary node-positive (pN+) breast carcinoma (study part B) regardless of intrinsic subtype 2. signed informed consent form 3. persons who are legally competent and mentally able to follow the instructions of the study personnel
Exclusion criteria
Exclusion criteria: 1. minor age 2. hypersensitivity/allergy to ultrasound contrast medium or its components sulphur hexafluoride, macrogol 4000, colfosceril stearate, 1-(1,2-dipalmitoyl-3-sn-phosphatidyl)glycerol sodium salt palmitic acid 3. right-left shunt 4. signs of cardiovascular instability 5. acute endocarditis 6. artificial heart valves 7. acute systemic inflammation and/or sepsis 8. overactive coagulation status and/or recent thromboembolism 9. end-stage renal or liver disease 10. severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg) 11. uncontrolled systemic hypertension 12. acute respiratory distress syndrome 13. pregnant women 14. persons who are institutionalized on official or judicial orders 15. persons who are in a dependent or employment relationship with the sponsor or investigator 16. alcohol and drug abuse 17. expected non-compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of sonographic sensitivity in preoperative re-evaluation after completion of neoadjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Improving the sensitivity of axillary sonography in the initial diagnosis of breast cancer | — |
Countries
Germany
Contacts
Public ContactElmar Stickeler
Uniklinik RWTH Aachen
Outcome results
None listed