Breast Cancer Clinical Trial
Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Summary
This phase II/III trial studies if contrast-enhanced ultrasound (CEUS) using a contrast agent, perflutren lipid microspheres (Definity), can predict the early response of breast cancer to neoadjuvant chemotherapy by estimating the pressure gradient between the breast cancer and surrounding tissues. To estimate the pressures noninvasively, subharmonic (half of fundamental frequency) aided pressure estimation (SHAPE) using CEUS will be utilized. The study hypothesis is that the subharmonic signal difference in the tumor relative to the normal tissue can predict breast cancer NAC response after 10% of therapy regimen.
Full Description
PRIMARY OBJECTIVE:
I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer.
SECONDARY OBJECTIVE:
I. To assess whether the accuracy of 3D SHAPE for predicting locally advanced breast cancer (LABC) NAC response varies with breast cancer subtype.
OUTLINE:
Patients undergo contrast-enhanced ultrasound (CEUS) and receive perflutren lipid microspheres intravenously (IV) over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC.
After completion of study, patients are followed up at the completion of NAC.
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:
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
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