C50
Conditions
Interventions
Group 1: Study Part A: Patients with primary breast carcinoma will receive ultrasound imaging to assess tumor size, location, and structure in the form of B-mode ultrasound, elastography, and contrast
Sponsors
Klinik für Gynäkologie und Geburtshilfe RWTH Aachen
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. patients with histologically confirmed primary breast carcinoma including all intrinsic subtypes (study part A and B) and patients with high-grade suspicion of primary breast carcinoma (study part C). 2. treatment with neoadjuvant chemotherapy (study part A and B) 3. written informed consent 4. subjects who are legally competent and mentally able to comply with the instructions of the study personnel
Exclusion criteria
Exclusion criteria: 1. minority 2. hypersensitivity / allergy to ultrasound contrast agent or its components sulfur 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 hepatic 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 by administrative or judicial order 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 |
|---|---|
| The goal of this project is to adapt the mULM to clinical application to study the discrimination of benign and malignant breast cancer tumors and the prediction and monitoring of breast cancer responses to neoadjuvant chemotherapy in an exploratory patient study. | — |
Countries
Germany
Contacts
Public ContactElmar Stickeler
Klinik für Gynäkologie und Geburtshilfe Uniklinik RWTH Aachen
Outcome results
None listed