This trial studies how well acoustic radiation force impulse (ARFI), viscoelastic response (VisR), and dynamic displacement anisotropy imaging (DDAI) ultrasound techniques work in diagnosing patients with breast cancer and if ultrasound can be used to determine which types of tumors respond to chemotherapy. Diagnostic techniques, such as ultrasound, may be a less invasive way to check for breast cancer and may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03785782.
PRIMARY OBJECTIVES:
I. Quantify the ability of ultrasound-derived stiffness, elasticity, viscosity, and anisotropy to detect malignancy.
Ia. Determine which of the 8 ultrasound metrics best detects malignancy.
Ib. Determine the combined diagnostic accuracy of any 2 ultrasound metrics.
Ic. Determine the combined diagnostic accuracy of ultrasound metrics and mammography.
Id. Determine which cutpoints for ultrasound metrics detect malignancy with optimum sensitivity and specificity.
II. Quantify the ability of ultrasound-derived stiffness, elasticity, viscosity, and anisotropy to predict a positive response to treatment.
IIa. Determine which baseline ultrasound metric best predicts positive response to neoadjuvant chemotherapy (NAC).
IIb. Determine which baseline ultrasound metric correlates most strongly with absolute reduction in tumor size.
IIc. Determine the combined ability of any 2 baseline ultrasound metrics for prediction of positive response to NAC.
IId. Determine if serial changes in ultrasound metrics correlate with positive response to NAC.
IIe. Determine for which of the 8 ultrasound metrics do serial changes best predict positive response to NAC.
IIf. Determine if combinations of changes over time in any ultrasound outcome metrics correlate with positive response to NAC.
IIg. Determine if combinations of serial change for any 2 ultrasound metrics predict positive response to NAC.
IIh. Determine the combined performance of ultrasound metrics and mammography for predicting a positive response to NAC.
IIi. Determine the sensitivity, specificity and positive predictive value (PPV) of ultrasound outcome metrics to predict positive response to NAC.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients with diagnosed Breast Imaging Reporting and Data System (BIRADS) 4a, 4b, 4c, or 5 masses undergo ARFI, VisR, and DDAI ultrasound over 15 minutes before scheduled biopsy.
ARM II: Patients with stage II or III breast cancer undergo ARFI, VisR, and DDAI ultrasound over 15 minutes before beginning chemotherapy, 2-3 weeks into chemotherapy, and after chemotherapy.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorCaterina Gallippi
