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

Phase 1

Terminated

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

• Registration Number: NCT02067884
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-12-19
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Primary Completion: 2016-09-25
• Study Completion: 2016-09-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CEUS, SWE)	dynamic contrast-enhanced ultrasound imaging	Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
Diagnostic (CEUS, SWE)	shear wave elastography	Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
Diagnostic (CEUS, SWE)	Definity, (Lipid Microspheres) Intravenous Suspension	Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
Diagnostic (CEUS, SWE)	Philips Shear Wave Elastography	Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.

Primary Outcome Measures

Name	Time	Method
Model predicted treatment response for CEUS and SWE	Up to 1 year	Weighted Kappa will be used to assess the agreement.
Pathologically determined treatment response for CEUS and SWE	Up to 1 year	Weighted Kappa will be used to assess the agreement.

Secondary Outcome Measures

Name	Time	Method
Treatment response predicted by novel ultrasound techniques	Up to 1 year	Weighted Kappa will be used to assess the agreement. Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
Treatment response predicted by CE MRI	Up to 1 year	Weighted Kappa will be used to assess the agreement. Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States