Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced Computed Tomography and/or Magnetic Resonance Imaging Using Sonazoid

Patients with a diagnosis of cancer or high probability of cancer (any primary) who have contraindications for a contrast enhanced Computed Tomography or Magnetic Resonance Image will be asked to participate in this study. Patients will be both male and female and be >18 years old. Contraindications for computer tomography (CT) or magnetic resonance imaging (MRI) would include, but not limited to:

1. Creatinine clearance of <60 mg/dl
2. Allergy to iodinated contrast or gadolinium based contrast agents
3. History of adverse event with CT or MRI contrast

Up to 100 patients will be enrolled over a two year period.

Statistical justification for sample size Assuming that a non-enhanced CT will detect and characterize metastatic disease correctly 60% of the time (2) and that Contrast enhanced ultrasound (CEUS) will detect and characterize metastatic disease correctly 90% of the time (3,4), there will be a 100% chance of a significant difference at a one-sided 0.05 significance level using the Fisher Exact Test.

CT and MRI Patient will receive the non-contrast CT or MRI that would be ordered as routine stating or follow-up of the patient. At a minimum 5mm contiguous axial slices will be obtained with CT and T1-weighted, T2-weighted, in-phase and out of phase imaging will be performed on MRI with a minimum slice thickness of 5mm. Each lesion noted within the liver will be measured in two dimensions and recorded. The lesion will be classified on a scale of 1 - 5 regarding the probability of benignity or malignancy of the lesion. If a diagnosis can be made the diagnosis will be documented The location of the lesion will be documented on a Couinaud diagram.