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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

Tracking Information
First Submitted Date July 14, 2010
First Posted Date July 15, 2010
Last Update Posted Date January 30, 2017
Study Start Date September 2010
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2010)
Predict RECIST response to treatment [ Time Frame: at 3 months from CT perfusion parameters before and after treatment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 14, 2010)
  • Characterize CT perfusion longitudinally in both responders and nonresponders [ Time Frame: 1 yr ]
  • Predict disease progression [ Time Frame: 1 yr ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
Official Title Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Neuroendocrine Tumors
  • Brain (Nervous System) Cancers
  • Colon/Rectal Cancer
  • Colon Cancer
  • Hepatobiliary Cancers
  • Hepatocellular Carcinoma (Hepatoma)
  • Liver
Intervention Procedure: CT perfusion
Study Groups/Cohorts
  • neuroendocrine metastases
    15 patients with neuroendocrine metastases
    Intervention: Procedure: CT perfusion
  • colon cancer metastases
    15 patients with colon cancer metastases
    Intervention: Procedure: CT perfusion
  • HCC treated with cyberknife radiation and chemotherapy
    15 patients with HCC treated with cyberknife radiation and chemotherapy
    Intervention: Procedure: CT perfusion
  • HCC treated with Sirsphere embolization and chemotherapy
    15 patients with HCC treated with Sirsphere embolization and chemotherapy
    Intervention: Procedure: CT perfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 22, 2016)
13
Original Estimated Enrollment
 (submitted: July 14, 2010)
60
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01163526
Other Study ID Numbers HEP0031
SU-07092010-6491 ( Other Identifier: Stanford University )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators
  • Siemens Corporation, Corporate Technology
  • GE Healthcare
Investigators
Principal Investigator: Aya Kamaya Stanford University
PRS Account Stanford University
Verification Date January 2017