RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2020-12-07
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04715958

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide signed and dated informed consent form
  2. * Willing to comply with all study procedures and be available for the duration of the study
  3. * At least 21 years old
  4. * Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)
  5. * Be scheduled for neoadjuvant chemotherapy
  6. * Be medically stable
  7. * Be conscious and able to comply with study procedures
  8. * If a female of child-bearing potential, must have a negative urine pregnancy test
  1. * Males
  2. * Females who are pregnant or nursing
  3. * Patients with other primary cancers requiring systemic treatment
  4. * Patients with any distal metastatic disease
  5. * Patients undergoing neoadjuvant endocrine therapy
  6. * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
  7. * Patients on life support or in a critical care unit;
  8. * Patients with unstable occlusive disease (e.g., crescendo angina);
  9. * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia;
  10. * Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class IV);
  11. * Patients with recent cerebral hemorrhage;
  12. * Patients who have undergone surgery within 24 hours prior to the study sonographic examination
  13. * Patients with known hypersensitivity or allergy to any component of Definity
  14. * Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
  15. * Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli

Contacts and Locations

Study Contact

Kibo Nam, MD
CONTACT
215-955-6261
Kibo.Nam@jefferson.edu

Principal Investigator

Kibo Nam, MD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Kibo Nam

  • Kibo Nam, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-07
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2020-12-07
Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

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