This clinical trial studies subharmonic imaging and interstitial pressure estimation in determining response to therapy before surgery in patients with breast cancer. Subharmonic imaging (SHI) is a type of ultrasound that uses a contrast agent called perflutren lipid microspheres (or Definity) to create pictures of tissues and organs inside the body. Tumors are known to have higher amounts of fluid found in the spaces between their tissues (interstitial fluid) than normal tissue and can measured using subharmonic imaging and pressure estimation (SHAPE). SHI and SHAPE using Definity contrast may allow doctors to see tiny blood vessels in the breast lesion and determine whether changes in these blood vessels and in interstitial pressure are related to treatment response.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02115607.
PRIMARY OBJECTIVES:
I. To evaluate the ability of 3-dimensional (3D) SHI and SHAPE to track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to magnetic resonance imaging (MRI) and pathology.
SECONDARY OBJECTIVES:
I. To compare the 3D SHI depiction of breast cancer angiogenesis in humans to cluster of differentiation (CD)31, an immunohistochemical predictor of angiogenesis.
OUTLINE:
Patients receive perflutren lipid microspheres intravenously (IV) and undergo 3D SHI and SHAPE at baseline, approximately at 10% and 60% of the neoadjuvant therapy, and after completion of treatment but before surgery.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorFlemming Forsberg
