A Phase 2/3 interventional study of Contrast-Enhanced Ultrasound and Perflutren Lipid Microspheres in Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, sponsored by Kibo Nam. Active, not recruiting at 3 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Kibo Nam · Phase 2/3, Interventional, and Diagnostic
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.
PRIMARY OBJECTIVE:
I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer.
SECONDARY OBJECTIVE:
I. To assess whether the accuracy of 3D SHAPE for predicting locally advanced breast cancer (LABC) NAC response varies with breast cancer subtype.
OUTLINE:
Patients undergo contrast-enhanced ultrasound (CEUS) and receive perflutren lipid microspheres intravenously (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.
After completion of study, patients are followed up at the completion of NAC.
This is the only study on the registry with Kibo Nam as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
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
Procedure: Contrast-Enhanced Ultrasound · Drug: Perflutren Lipid Microspheres · Procedure: Ultrasound
Undergo CEUS
Also known as: CEUS
Given IV
Also known as: Definity
Undergo unenhanced baseline ultrasound
Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
3-dimensional (3D) tumor measurements over the three ultrasound exams will be recorded for each subject to calculate tumor volume changes with NAC. The tumor volume change during the therapy will be compared to imaging (magnetic resonance imaging or ultrasound) and pathologic response as well as to the corresponding 3D subharmonic aided pressure estimation (SHAPE) results.
Time frame: Up to study completion (48 months)
Prediction of the patients' clinical and pathological response
The SHAPE results from three time points (i.e. before, 10% completion, and 30% completion of NAC) will be modeled for predicting the patients' clinical response as well as pathological response using longitudinal logistic regression with adjustment for correlated observations over time by generalized linear mixed effects or generalized estimating equations (GEE) modeling.
Time frame: Up to study completion (48 months)
The ability of the SHAPE method to distinguish responders from non-responders
Will also be compared using receiver operating characteristic analysis to develop thresholds for decision-making based on balancing sensitivity and specificity.
Time frame: Up to study completion (48 months)
Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype
The variation of the accuracies of the SHAPE results by breast cancer subtypes will be reported. The generalized linear mixed effects or GEE modeling will be stratified by breast cancer subtype and also extended to include modeling of breast cancer subtype as a main effect and as an interaction effect with SHAPE.
Time frame: Up to study completion (48 months)
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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