Using ultrasound to predict chemotherapy response in advanced breast cancer
Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
This study is testing if a special type of ultrasound can help predict how well chemotherapy will work for people with locally advanced breast cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Rochester, Minnesota and 2 other locations) |
| Trial ID | NCT04715958 on ClinicalTrials.gov |
What this trial studies
This phase II/III trial investigates whether contrast-enhanced ultrasound, utilizing perflutren lipid microspheres, can effectively predict the response to neoadjuvant chemotherapy in patients with locally advanced breast cancer. The study aims to evaluate a novel biomarker called 3D subharmonic aided pressure estimation (3D SHAPE) to assess the pressure within tumors, which may influence treatment efficacy. Patients will undergo a series of ultrasound imaging sessions before and during chemotherapy to monitor changes and responses. The trial will also explore how the accuracy of this method varies across different breast cancer subtypes.
Who should consider this trial
Good fit: Ideal candidates include women aged 21 and older diagnosed with locally advanced breast cancer who are scheduled for neoadjuvant chemotherapy.
Not a fit: Patients who are male, pregnant, nursing, or have other primary cancers or distal metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment plans for patients with locally advanced breast cancer.
How similar studies have performed: While the use of ultrasound in cancer treatment is established, the specific application of 3D SHAPE for predicting chemotherapy response is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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
Where this trial is running
Rochester, Minnesota and 2 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kibo Nam, MD — Thomas Jefferson University
- Study coordinator: Kibo Nam, MD
- Email: Kibo.Nam@jefferson.edu
- Phone: 215-955-6261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.