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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT04715958
Eligibility Criteria:
Inclusion Criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* At least 21 years old
* Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)
* Be scheduled for neoadjuvant chemotherapy
* Be medically stable
* Be conscious and able to comply with study procedures
* If a female of child-bearing potential, must have a negative urine pregnancy test
Exclusion Criteria:
* Males
* Females who are pregnant or nursing
* Patients with other primary cancers requiring systemic treatment
* Patients with any distal metastatic disease
* Patients undergoing neoadjuvant endocrine therapy
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
* Patients on life support or in a critical care unit;
* Patients with unstable occlusive disease (e.g., crescendo angina);
* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia;
* Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class IV);
* Patients with recent cerebral hemorrhage;
* Patients who have undergone surgery within 24 hours prior to the study sonographic examination
* Patients with known hypersensitivity or allergy to any component of Definity
* Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
* Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04715958
Study Brief:
Protocol Section:
NCT04715958