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Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging followed by quantitative VCEUS imaging:

1. prior to initiation of treatment (baseline);
2. at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);
3. at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);
4. 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.

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.

2D US grayscale plus quantitative VCEUS

Mark E Lockhart, MD

1. 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.
2. 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.

Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy

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

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.

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.

Pathology residual tumor measured in millimeters

American Cancer Society, Inc.

University of Alabama at Birmingham

Professor

Patients with breast cancer receiving neoadjuvant chemotherapy will undergo quantitative VCEUS imaging and 2D grayscale imaging as follows:

1. prior to initiation of treatment (baseline);
2. at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);
3. at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);
4. 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.

Definity (Perflutren Lipid Microspheres): 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.

Definity VCEUS

Evaluation of VCEUS to Determine Response to Chemotherapy

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Total number of participants is 6. All participants received both interventions.

Marianne Vetrano

Patients with breast cancer receiving neoadjuvant chemotherapy will undergo a 2D grayscale imaging prior to initiation of treatment (baseline);

Grayscale Ultrasound

Tumor Volume Measure Using Grayscale US

Time from contrast injection to peak intensity

VCEUS Perfusion Time to Peak

1 subject did not complete this timepoint due to machine down

Pathology Residual

Pathology Residual Tumor

Patients with breast cancer receiving neoadjuvant chemotherapy will undergo 2D grayscale imaging followed by the quantitative VCEUS imaging as follows:

1. prior to initiation of treatment (baseline);
2. at 14 (± 4 days) after initiation of neoadjuvant chemotherapy (early treatment);
3. at 28 days (± 4 days) after initiation of neoadjuvant chemotherapy (inter-regimen);
4. 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.

Definity (Perflutren Lipid Microspheres): 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.

Spots Global Cancer Trial Database for 2d us grayscale plus quantitative vceus