Pilot Feasibility Study on 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Patients With Liver Metastases
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 colon adenocarcinomas. 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.
Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of
chemotherapy, at 2 weeks, and at 2 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types. Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type. Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type. Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.
United States: Institutional Review Board
|Stanford University||Stanford, California 94305|