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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
  Purpose

Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor.


Condition Intervention
Kidney (Renal Cell) Cancer
 Device: dTA/dBA C-arm fluoroscopy system with Dyna CT
Procedure: DSA arteriogram- hepatic arteries
Procedure: CO2 aortogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of C-arm CT in Patients With Decreased Renal Function Undergoing Transhepatic Arterial Chemoembolization (TACE) for the Treatment of Hepato-Cellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  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

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).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326390

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Nishita N. Kothary Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01326390     History of Changes
Other Study ID Numbers: HEP0035, SU-07012010-6469
Study First Received: July 6, 2010
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 19, 2013