Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer

Description

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.

Conditions

Anatomic Stage III Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer

Condition
Anatomic Stage III Breast Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Dallas

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Males
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kibo Nam,

Kibo Nam, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

2026-05-31