Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kibo Nam

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