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

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

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

Condition or disease Intervention/treatment
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
Actual Enrollment : 13 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources


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


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01326390     History of Changes
Other Study ID Numbers: HEP0035
SU-07012010-6469 ( Other Identifier: Stanford University )
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

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