Status:
UNKNOWN
KVUS at Neoadjuvant CTx of Breast Cancer
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Univ.-Prof. Dr. med. F. Kiessling
Conditions:
Early Primary Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
Detailed Description
The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is urgently neede...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03385200
Start Date
December 12 2016
End Date
December 12 2019
Last Update
December 28 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Gynecology and Obstetrics
Aachen, Germany