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

This study is currently recruiting participants.
Verified March 2014 by Stanford University
Sponsor:
Collaborators:
Siemens Healthcare Sector
GE Healthcare
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01163526
First received: July 14, 2010
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine whether baseline CT perfusion characteristics (measurements of blood-flow using CT) of hepatic cancers can predict tumor response to treatment and whether perfusion CT after treatment can be used as a biomarker for response to treatment. Treatment may consist of chemotherapy or stereotactic body radiotherapy (SBRT)or embolization therapy.


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
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: Euodia Jonathan    650-723-7419    euodia@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 Healthcare Sector
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: March 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014