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

• Sponsor: Stanford University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01326390
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

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

Study Design

• 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 1, 2010
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Outcome Measures

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) [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Nishita N. Kothary, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT01326390
• Other Study ID Numbers: HEP0035; SU-07012010-6469
• First Posted: Mar 30, 2011
• Last Update Posted: Jul 1, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Carcinoma, Hepatocellular; Carcinoma, Renal Cell

Study Results

No Results Posted as of Jul 1, 2016