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

Terminated

• Conditions: Liver; Neuroendocrine Tumors; Colon Cancer; Brain (Nervous System) Cancers; Colon/Rectal Cancer; Hepatobiliary Cancers; Hepatocellular Carcinoma (Hepatoma)
• Interventions: Procedure: CT perfusion

• Registration Number: NCT01163526
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Study Start: 2010-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
colon cancer metastases	CT perfusion	15 patients with colon cancer metastases
HCC treated with cyberknife radiation and chemotherapy	CT perfusion	15 patients with HCC treated with cyberknife radiation and chemotherapy
neuroendocrine metastases	CT perfusion	15 patients with neuroendocrine metastases
HCC treated with Sirsphere embolization and chemotherapy	CT perfusion	15 patients with HCC treated with Sirsphere embolization and chemotherapy

Primary Outcome Measures

Name	Time	Method
Predict RECIST response to treatment	at 3 months from CT perfusion parameters before and after treatment

Secondary Outcome Measures

Name	Time	Method
Predict disease progression	1 yr
Characterize CT perfusion longitudinally in both responders and nonresponders	1 yr

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States