Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Kibo Nam
Summary
This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.
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 underg…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
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 * P…
Interventions
- ProcedureContrast-Enhanced Ultrasound
Undergo CEUS
- DrugPerflutren Lipid Microspheres
Given IV
- ProcedureUltrasound
Undergo unenhanced baseline ultrasound
Locations (3)
- Mayo ClinicRochester, Minnesota
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania
- UT Southwestern/Simmons Cancer Center-DallasDallas, Texas