Clinical trial NCT02067884: Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery
Official title: Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: L K Whittier Foundation
First posted: 2014-02-20
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Model predicted treatment response for CEUS and SWE
timeFrame: Up to 1 year
measure: Pathologically determined treatment response for CEUS and SWE
timeFrame: Up to 1 year
Secondary outcomes:
measure: Treatment response predicted by novel ultrasound techniques
timeFrame: Up to 1 year
measure: Treatment response predicted by CE MRI
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Linda Hovanessian-Larsen
role: PRINCIPAL_INVESTIGATOR
References: