Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases

PRIMARY OBJECTIVES:

I. The purpose of this study is to perform a pilot feasibility study on 3-dimensional (3D)
ultrasound imaging of liver metastases and to evaluate whether perfusion characteristics
(measurements of blood-flow) of hepatic metastases can predict tumor response to treatment in
patients with liver metastases. The investigators long term goal is to assess whether early
perfusion changes at 2 weeks after chemotherapy initiation can be used as a non-invasive
early biomarker for treatment response assessment.

OUTLINE:

Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of
chemotherapy, at 2 weeks, and at 2 months.

Inclusion Criteria

- Provides written Informed Consent and is willing to comply with protocol requirements.

- Has at least 1 focal lesion in liver or kidney

- Patient may be (i) in the process of receiving treatment (1 scan session), (ii) never
treated (3 scan sessions) or (iii) changing treatment regimen/ type and/or receiving a
new form of treatment and/or has been on a treatment break ('holiday')(3 scan session)

- Is at least18 years of age.

Exclusion Criteria

- Is determined by the Investigator that the subject is clinically unsuitable for the
study.

- Known right to left cardiac shunt, bidirectional or transient.

- Hypersensitivity to perflutren.

- Hypersenstivity to the contrast agent Definity.

- Pregnant and lactating women