This clinical trial studies the use of contrast enhanced ultrasound (CEUS) with US microvessel imaging compared with contrast enhanced dual energy mammography (CEGD) or contrast enhanced MR (CEMR) in detecting breast cancer in patients with suspicious breast lesions. Diagnostic procedures such as CEUS with US microvessel imaging uses small bubbles to detect blood flow with ultrasound and may be used to evaluate the breast lesion and other small lesions which currently can only be seen with magnetic resonance imaging (MRI).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03954015.
PRIMARY OBJECTIVE:
I. To estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.
SECONDARY OBJECTIVES:
I. Positive predictive value of CEDM in detecting lesions seen on MR.
II. Estimate the negative predictive value (true negative [TN]/[TN+ false negative [FN]]) of CEUS as an adjunct.
III. Compare the frequency of recommendation of biopsy of mammography (MG)±ultrasound (US) versus (vs) MG +/- US plus CEUS as an adjunct based on Breast Imaging Reporting and Data System (BIRADS) scores.
IV. Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR .
OUTLINE:
Prior to standard of care biopsy, patients receive iohexol (Omnipaque 350) intravenously (IV) and undergo CEDM over 5-6 minutes and standard of care CEMR. Patients also receive sulfur hexafluoride lipid microspheres (Lumason) IV and undergo CEUS. Patients then undergo standard of care image guide biopsy.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorKatrina N. Glazebrook
