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RECRUITING
NCT04715958
PHASE2/PHASE3

SHAPE Neoadjuvant Chemotherapy Response

Sponsor: Kibo Nam

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2020-12-07

Completion Date

2026-10-31

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

PROCEDURE

Contrast-Enhanced Ultrasound

Undergo CEUS

DRUG

Perflutren Lipid Microspheres

Given IV

PROCEDURE

Ultrasound

Undergo unenhanced baseline ultrasound

Locations (3)

Mayo Clinic

Rochester, Minnesota, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States