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

This study has been terminated.
(accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163526
First Posted: July 15, 2010
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Siemens Corporation, Corporate Technology
GE Healthcare
Information provided by (Responsible Party):
Stanford University
  Purpose
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 Intervention
Neuroendocrine Tumors Brain (Nervous System) Cancers Colon/Rectal Cancer Colon Cancer Hepatobiliary Cancers Hepatocellular Carcinoma (Hepatoma) Liver Procedure: CT perfusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

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

Enrollment: 13
Study Start Date: September 2010
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Aya Kamaya Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01163526     History of Changes
Other Study ID Numbers: HEP0031
SU-07092010-6491 ( Other Identifier: Stanford University )
First Submitted: July 14, 2010
First Posted: July 15, 2010
Last Update Posted: January 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neuroendocrine Tumors
Carcinoid Tumor
Colorectal Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases