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

University of Southern California

Status and phase: Terminated; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: shear wave elastography; Drug: Definity, (Lipid Microspheres) Intravenous Suspension; Procedure: dynamic contrast-enhanced ultrasound imaging; Device: Philips Shear Wave Elastography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02067884

NCI-2014-00085 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

1B-13-8 (Other Identifier)

Details and patient eligibility

About

This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.

Full description

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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Diagnostic (CEUS, SWE)

Experimental group

Description:

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

Treatment:

Device: Philips Shear Wave Elastography

Procedure: dynamic contrast-enhanced ultrasound imaging

Drug: Definity, (Lipid Microspheres) Intravenous Suspension

Procedure: shear wave elastography