Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery
NCT ID: NCT02067884
Last Updated: 2019-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
34 participants
INTERVENTIONAL
2013-12-19
2016-09-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
dynamic contrast-enhanced ultrasound imaging
Undergo CEUS
shear wave elastography
Undergo SWE
Definity, (Lipid Microspheres) Intravenous Suspension
Participant will receive contrast agent by intravenous administration
Philips Shear Wave Elastography
Equipment used for SWE
Interventions
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dynamic contrast-enhanced ultrasound imaging
Undergo CEUS
shear wave elastography
Undergo SWE
Definity, (Lipid Microspheres) Intravenous Suspension
Participant will receive contrast agent by intravenous administration
Philips Shear Wave Elastography
Equipment used for SWE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
L K Whittier Foundation
UNKNOWN
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Linda Hovanessian-Larsen
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2014-00085
Identifier Type: REGISTRY
Identifier Source: secondary_id
1B-13-8
Identifier Type: OTHER
Identifier Source: secondary_id
1B-13-8
Identifier Type: -
Identifier Source: org_study_id
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