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

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ClinicalTrials.gov Identifier: NCT01163526
Recruitment Status : Terminated (accrual)
First Posted : July 15, 2010
Last Update Posted : January 30, 2017
Sponsor:
Collaborators:
Siemens Corporation, Corporate Technology
GE Healthcare
Information provided by (Responsible Party):
Stanford University

Study Description
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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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Brain (Nervous System) Cancers Colon/Rectal Cancer Colon Cancer Hepatobiliary Cancers Hepatocellular Carcinoma (Hepatoma) Liver Procedure: CT perfusion

Study Design
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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
Study Start Date : September 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
neuroendocrine metastases
15 patients with neuroendocrine metastases
 Procedure: CT perfusion
colon cancer metastases
15 patients with colon cancer metastases
 Procedure: CT perfusion
HCC treated with cyberknife radiation and chemotherapy
15 patients with HCC treated with cyberknife radiation and chemotherapy
 Procedure: CT perfusion
HCC treated with Sirsphere embolization and chemotherapy
15 patients with HCC treated with Sirsphere embolization and chemotherapy
 Procedure: CT perfusion


Outcome Measures
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Primary Outcome Measures :
  1. Predict RECIST response to treatment [ Time Frame: at 3 months from CT perfusion parameters before and after treatment ]

Secondary Outcome Measures :
  1. Characterize CT perfusion longitudinally in both responders and nonresponders [ Time Frame: 1 yr ]
  2. Predict disease progression [ Time Frame: 1 yr ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163526


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Siemens Corporation, Corporate Technology
GE Healthcare
Investigators
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Principal Investigator: Aya Kamaya Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01163526    
Other Study ID Numbers: HEP0031
SU-07092010-6491 ( Other Identifier: Stanford University )
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neoplasms by Histologic Type
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue