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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01326390
First received: July 6, 2010
Last updated: February 2, 2012
Last verified: February 2012
History of Changes

July 6, 2010
February 2, 2012
May 2010
September 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01326390 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
September 2012
September 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01326390
HEP0035, SU-07012010-6469
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Nishita N. Kothary Stanford University
Stanford University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP