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

Kidney (Renal Cell) Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01326390
• Other study ID #: HEP0035
• Secondary ID: SU-07012010-6469
• Status: Terminated
• Phase: N/A
• First received: July 6, 2010
• Last updated: June 30, 2016
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Carcinoma, Renal Cell
• Kidney (Renal Cell) Cancer

Intervention

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

Procedure:
• DSA arteriogram- hepatic arteries
Standard of care
• CO2 aortogram
Standard of care

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		3 weeks	No