Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT05445050
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05445050
Study Brief:
Protocol Section:
NCT05445050