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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02067884
• Other study ID #: 1B-13-8
• Secondary ID: NCI-2014-000851B
• Status: Terminated
• Phase: Phase 1
• Start date: December 19, 2013
• Est. completion date: September 25, 2016

Study information

• Verified date: January 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: September 25, 2016
• Est. primary completion date: September 25, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• dynamic contrast-enhanced ultrasound imaging
Undergo CEUS
• shear wave elastography
Undergo SWE

Drug:
• Definity, (Lipid Microspheres) Intravenous Suspension
Participant will receive contrast agent by intravenous administration

Device:
• Philips Shear Wave Elastography
Equipment used for SWE

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	L K Whittier Foundation, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Model predicted treatment response for CEUS and SWE	Weighted Kappa will be used to assess the agreement.	Up to 1 year
Primary	Pathologically determined treatment response for CEUS and SWE	Weighted Kappa will be used to assess the agreement.	Up to 1 year
Secondary	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
Secondary	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