Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings utilizing final surgical pathology and clinical outcome. Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion measurements and enhancement patterns in predicting tumor response to adjuvant treatment in clinical studies. The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound (echocardiography) of the heart. Definity® will be used off-label (during ultrasound of the breast) in this study. The administration of Definity® during this study will follow total dose guidelines approved by the FDA.

Official Title
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A Pilot Study Evaluating Quantitative Volume Contrast Enhanced Ultrasound (VCEUS) Imaging for Determining Early Breast Cancer Response to Neoadjuvant Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: 2D US grayscale plus quantitative VCEUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age 19 years or older). Patients with newly diagnosed and untreated stage II and III breast cancer scheduled to undergo neoadjuvant chemotherapy. Patients with signed informed consent. Exclusion Criteria: Any history of prior radiation or chemotherapy for breast cancer. Patients who only have non-measurable disease. Patients who are medically unstable. Patients with other primary cancers requiring systemic treatment. Patients with cardiac shunts. Patients with unstable cardiopulmonary conditions. Patients with known pulmonary hypertension. Patients with known hypersensitivity to any component of Definity (R) microbubble contrast. Patients who are pregnant, breast-feeding or are planning to become pregnant during the study duration.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2D US grayscale plus quantitative VCEUS<br>Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging followed by quantitative VCEUS imaging: prior to initiation of treatment (baseline); at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment); at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen); at completion of therapy prior to definitive surgery (usually 2-3 months after initiation of treatment). Each patient will undergo a total of four VCEUS examinations. | Diagnostic Test: 2D US grayscale plus quantitative VCEUS<br>* This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens.<br>* Other names: Definity VCEUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Baseline (first visit) | 
| VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Baseline | 
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Week 2 | 
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | Week 4 | 
| Tumor Volume Measure Using Grayscale US | Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters. | 6 months | 
| VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Week 2 | 
| VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | Week 4 | 
| VCEUS Perfusion Time to Peak | Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathology Residual Tumor | Pathology residual tumor measured in millimeters | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Definity, Ultrasound