Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery

PRIMARY OBJECTIVES:

I. To establish a quantitative prediction rule for accurate and early prediction of the
pathologic tumor response assessed post-surgery, using the change of contrast enhanced
ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3
weeks following initiation of neoadjuvant chemotherapy (NAC).

II. To assess the agreement between CEUS based classification rule and pathologically
determined treatment response (baseline versus pre-surgical scan).

III. To establish a quantitative prediction rule for accurate and early prediction of the
pathologic tumor response assessed post-surgery, using the change in propagation velocity of
a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of
NAC.

IV. To assess the agreement between shear wave elastography (SWE) based classification rule
and pathologically determined treatment response (baseline versus pre-surgical scan).

SECONDARY OBJECTIVES:

I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3
weeks following initiation of NAC), in accurately predicting the pathologically determined
tumor response.

II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus
contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline
versus pre-surgery scan and to identify discordant cases using scatter plot and contingency
tables.

OUTLINE:

Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at
baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.

Inclusion Criteria:

- Women with histologically confirmed breast cancer (by core needle biopsy)

- Women with >= 2 cm clinically or radiologically measureable breast cancer

- Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan

- Women competent to sign study specific written Informed Consent

- Women willing to comply with protocol requirements

Exclusion Criteria:

- Women who are pregnant

- Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis

- Women who have had a prior history of breast cancer in the same breast

- Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to
perflutren agent

- Women who cannot consent for themselves