Colon Cancer Clinical Trial

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

Summary

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

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

34

Study ID:

NCT01631318

Recruitment Status:

Completed

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University
Stanford California, 94305, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

34

Study ID:

NCT01631318

Recruitment Status:

Completed

Sponsor:


Stanford University

How clear is this clinincal trial information?

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