Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies

Study Overview
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Brief Summary
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A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.

Official Title
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Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies

Conditions
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Neuroendocrine Tumors, Brain (Nervous System) Cancers, Colon/Rectal Cancer, Colon Cancer, Hepatobiliary Cancers, Hepatocellular Carcinoma (Hepatoma), Liver

Intervention / Treatment
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* Procedure: CT perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:3.1.1 Patients with suspected or biopsy-proven liver masses including unresectable hepatocellular carcinoma (HCC), unresectable colon cancer metastases to the liver, and metastatic neuroendocrine tumors to the liver will be eligible for enrollment. 3.1.2 Patients who have undergone prior chemotherapy more than one year prior to the study are eligible for enrollment. 3.1.4 Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant. 3.1.5 No life expectancy restrictions. 3.1.6 ECOG and Karnofsky Performance Status will not be employed. 3.1.7 Patients with renal failure are ineligible for this study (Glomerular filtration rate (GFR) must be > 60) 3.1.8 Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria:3.2.1 Patients who have undergone prior chemoembolization of hepatocellular carcinoma (HCC) are ineligible for enrollment. Patients who have undergone chemotherapy within one year prior to the study are also ineligible for enrollment. 3.2.2 No restrictions regarding use of other investigational agents. 3.2.3 Patients with severe contrast allergy are ineligible. 3.2.4 Patients who are pregnant or are trying to become pregnant are excluded from this study. 3.2.5 Patients who are cancer survivors or Human Immunodeficiency Virus (HIV)-positive will not be excluded.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neuroendocrine metastases<br>15 patients with neuroendocrine metastases | Procedure: CT perfusion<br> <br> |
| colon cancer metastases<br>15 patients with colon cancer metastases | Procedure: CT perfusion<br> <br> |
| HCC treated with cyberknife radiation and chemotherapy<br>15 patients with HCC treated with cyberknife radiation and chemotherapy | Procedure: CT perfusion<br> <br> |
| HCC treated with Sirsphere embolization and chemotherapy<br>15 patients with HCC treated with Sirsphere embolization and chemotherapy | Procedure: CT perfusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predict RECIST response to treatment |  | at 3 months from CT perfusion parameters before and after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize CT perfusion longitudinally in both responders and nonresponders |  | 1 yr | 
| Predict disease progression |  | 1 yr |