Liver Metastases, Colon Cancer
Conditions
Brief 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
Detailed 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.
Interventions
Ultrasound imaging procedure
DEVICEOptical Tracking Device
Optical Tracking Device, manufactured by Atracsys LLC, Switzerland.
DEVICEElectromagnetic Tracking Device
Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont.
DRUGPerflutren
Perflutren lipid microsphere, IV 0.4 mL. Used as standard contrast agent, not the subject of the study.
Sponsors
National Cancer Institute (NCI)
Philips Healthcare
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline | 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. |
Countries
United States
Outcome results
None listed