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

Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (CEUS, SWE); Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.

Procedure: dynamic contrast-enhanced ultrasound imaging; Undergo CEUS; Other Names: DCE-USI; Procedure: shear wave elastography; Undergo SWE; Other Names: SWE; Drug: Definity, (Lipid Microspheres) Intravenous Suspension; Participant will receive contrast agent by intravenous administration; Other Names: Perflutren Lipid Microsphere; Device: Philips Shear Wave Elastography; Equipment used for SWE; Other Names: Shear Wave Elastography

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response predicted by novel ultrasound techniques	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.	Up to 1 year
Treatment response predicted by CE MRI	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.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI); L K Whittier Foundation
• Investigators: Principal Investigator: Linda Hovanessian-Larsen, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2013
• Primary Completion (Actual): September 25, 2016
• Study Completion (Actual): September 25, 2016

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1B-13-8 (Other Identifier: USC Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2014-00085 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes