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

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Contrast-Enhanced Ultrasound+Perflutren Lipid Microspheres
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Texas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
Contact Information
Primary
Kibo Nam, MD
Kibo.Nam@jefferson.edu
215-955-6261
Time Frame
Start Date: 2020-12-07
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 200
Treatments
Experimental: Diagnostic (CEUS, Definity)
Patients undergo CEUS and receive perflutren lipid microspheres 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
Related Therapeutic Areas
Sponsors
Leads: Kibo Nam
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov