mULM to Support Breast Cancer Diagnosis and Therapy
Primary Breast Cancer
About this trial
This is an interventional diagnostic trial for Primary Breast Cancer focused on measuring breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
Eligibility Criteria
Inclusion Criteria:
- written informed consent
- age ≥ 18 yrs
- histologically confirmed primary breast cancer including all intrinsic subtypes (study parts A and B)
- highly suspected primary breast cancer (study part C)
- treatment with neoadjuvant chemotherapy (study part B)
- persons who are legally competent and mentally able to follow the instructions of the study team
Exclusion Criteria:
- younger than 18 years
- hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- right-left shunt,
- signs of cardiovascular instability
- acute endocarditis
- artificial heart valves
- acute systemic inflammation and/or sepsis
- overactive coagulation status and/or recent thromboembolic events
- end stage of liver and kidney diseases
- 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
Sites / Locations
- Department of Gynecology and Obstetrics Universitätsklinikum Aachen, AöRRecruiting
Arms of the Study
Arm 1
Other
clinical application of mULM to support breast cancer diagnosis and therapy
The study arm includes three parts A, B and C. In part A, the scan protocol, including the injection of the clinically approved contrast agent SonoVue® and the data acquisition time range, is optimized based on the mULM measurements of participants with primary breast cancer. The following part B consists of 2D-mULM measurements applied to triple-negative breast cancer patients throughout their neoadjuvant chemotherapy cycles with the aim to evaluate to which degree 2D-mULM allows for an assessment of the tumor response during therapy. In the last part C, participants with neoplasms of uncertain dignity will be investigated by 2D- and 3D-mULM measurements and the accuracy of differentiation between the lesions assessed.