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

Study Overview
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Brief Summary
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Patients are invited to participate in a research study of liver perfusion (how blood flows to the liver over time). Researchers hope to learn whether perfusion characteristics of liver metastases may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment. Patients were selected as a possible participant in this study because they are identified as having liver metastases

Detailed Description
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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.

Official Title
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Pilot Technical Feasibility Study on 3D Contrast-enhanced Ultrasound Imaging and to Assess Whether Change in Ultrasound 3D Perfusion Pattern Can Predict Treatment Response

Conditions
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Liver Metastases, Colon Cancer

Intervention / Treatment
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* Procedure: Dynamic contrast-enhanced ultrasound imaging
* Device: Optical Tracking Device
* Device: Electromagnetic Tracking Device
* Drug: Perflutren


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (3D contrast-enhanced ultrasound imaging)<br>Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks. | Procedure: Dynamic contrast-enhanced ultrasound imaging<br>* Ultrasound imaging procedure<br>* Other names: 3D contrast enhanced ultrasound imaging;Device: Optical Tracking Device<br>* Optical Tracking Device, manufactured by Atracsys LLC, Switzerland.<br>Device: Electromagnetic Tracking Device<br>* Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont.<br>Drug: Perflutren<br>* Perflutren lipid microsphere, IV 0.4 mL. Used as standard contrast agent, not the subject of the study.<br>* Other names: Definity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | 2 weeks after chemotherapy initiation | 
| 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. | 2 months post-treatment |