Impact of C-arm CT in Decreased Renal Function Undergoing TACE for Tx of Hepato-Cellular Carcinoma

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. Identifier: NCT01326390
Recruitment Status : Terminated
First Posted : March 30, 2011
Last Update Posted : July 1, 2016
Information provided by (Responsible Party):
Stanford University

July 6, 2010
March 30, 2011
July 1, 2016
May 2010
January 2012   (Final data collection date for primary outcome measure)
Proportion of patients that develop renal failure (defined as a decline of renal function, as measured by glomerular filtration rate, of 25% or more from pre-procedural) [ Time Frame: 3 weeks ]
Same as current
Complete list of historical versions of study NCT01326390 on Archive Site
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Impact of C-arm CT in Decreased Renal Function Undergoing TACE for Tx of Hepato-Cellular Carcinoma
Impact of C-arm CT in Patients With Decreased Renal Function Undergoing Transhepatic Arterial Chemoembolization (TACE) for the Treatment of Hepato-Cellular Carcinoma
Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
All patients we are seeking will already have been scheduled to undergo liver Transhepatic arterial chemoembolizationWorld Health Organization treatment using C-arm CT as the imaging guidance (with limited Digital Subtraction angiography as needed).
Kidney (Renal Cell) Cancer
  • Device: dTA/dBA C-arm fluoroscopy system with Dyna CT
    C-arm CT of the liver; state-of-the-art flat panel detector on a ceiling or floor mounted C-arm gantry
    Other Names:
    • X-ray image intensifier
    • Siemens Angiography systems
  • Procedure: DSA arteriogram- hepatic arteries
    Standard of care
    Other Names:
    • Angiography
    • arteriography
  • Procedure: CO2 aortogram
    Standard of care
    Other Name: Aortography
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must be affected by HCC
  2. Patients must have diminished renal function (GFR<60 ml/min/1.73m^2)
  3. Patients must be 18 years old or older
  4. Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.
  5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Subjects under the age of 18
  2. Patients currently on dialysis
  3. Pregnant women
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
SU-07012010-6469 ( Other Identifier: Stanford University )
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Stanford University
Stanford University
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Principal Investigator: Nishita N. Kothary Stanford University
Stanford University
June 2016