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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Collaborators:
Siemens Corporation, Corporate Technology
GE Healthcare
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01163526
First received: July 14, 2010
Last updated: July 21, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize CT perfusion longitudinally in both responders and nonresponders [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • Predict disease progression [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163526

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Elizabeth Chitouras    650-498-0623    echitouras@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Aya Kamaya         
Sub-Investigator: Juergen Karl Willmann         
Sub-Investigator: Samuel So         
Sub-Investigator: Dr. John D Louie         
Sub-Investigator: Pamela Kunz         
Sub-Investigator: Nishita N. Kothary         
Sub-Investigator: Albert Koong         
Sub-Investigator: Dominik Fleischmann         
Sub-Investigator: George Albert Fisher M.D. Ph.D.         
Sub-Investigator: Cheryl Cho-Phan         
Sub-Investigator: Daniel T Chang         
Sponsors and Collaborators
Stanford University
Siemens Corporation, Corporate Technology
GE Healthcare
Investigators
Principal Investigator: Aya Kamaya Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01163526     History of Changes
Other Study ID Numbers: HEP0031, SU-07092010-6491
Study First Received: July 14, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neuroendocrine Tumors
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

ClinicalTrials.gov processed this record on September 30, 2014