Breast Cancer
Conditions
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.
Interventions
Undergo CEUS
PROCEDUREshear wave elastography
Undergo SWE
Participant will receive contrast agent by intravenous administration
Equipment used for SWE
Sponsors
National Cancer Institute (NCI)
L K Whittier Foundation
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed