Overview
KVUS at Neoadjuvant CTx of Breast Cancer
Status:
Unknown status
Unknown status
Trial end date:
2019-12-12
2019-12-12
Target enrollment:
0
0
Participant gender:
All
All
Summary
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapyPhase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
RWTH Aachen UniversityCollaborator:
Univ.-Prof. Dr. med. F. Kiessling
Criteria
Inclusion Criteria:- written informed consent
- age > 18 yrs
- histologically confirmed primary breast cancer including all intrinsic subtypes
- treatment with neoadjuvant chemotherapy
- persons who are legally competent and mentally able to follow the instructions of the
study team
Exclusion Criteria:
- hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000,
distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- right-left shunt,
- severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
- uncontrolled systemic hypertension
- acute respiratory distress syndrome
- pregnancy
- commitment of the patient to any resident institution by order of any court or
authority
- expectation of missing compliance
- alcohol or drug abuse
- patients who are in a relationship of dependence or in a working relationship to the
sponsor, the investigator or his representative