Overview

KVUS at Neoadjuvant CTx of Breast Cancer

Status:
Unknown status
Trial end date:
2019-12-12
Target enrollment:
0
Participant gender:
All
Summary
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
RWTH Aachen University
Collaborator:
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