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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01008 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1R01CA195443 | U.S. NIH Grant/Contract | View source | |
| HEP0043 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Philips Healthcare | INDUSTRY |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (3D contrast-enhanced ultrasound imaging) | Experimental | Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic contrast-enhanced ultrasound imaging | Procedure | Ultrasound imaging procedure |
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| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Aya Kamaya | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| Optical Tracking Device | Device | Optical Tracking Device, manufactured by Atracsys LLC, Switzerland. |
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| Electromagnetic Tracking Device | Device | Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont. |
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| Perflutren | Drug | Perflutren lipid microsphere, IV 0.4 mL. Used as standard contrast agent, not the subject of the study. |
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|
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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