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

NCT01326390 | Terminated DMC

• 2 other identifiers: HEP0035SU-07012010-6469
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney (Renal Cell) Cancer

Outcome Measures

Primary Outcomes (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

Interventions

dTA/dBA C-arm fluoroscopy system with Dyna CT DEVICE

C-arm CT of the liver; state-of-the-art flat panel detector on a ceiling or floor mounted C-arm gantry

Also known as: X-ray image intensifier, Siemens Angiography systems

DSA arteriogram- hepatic arteries PROCEDURE

Standard of care

Also known as: Angiography, arteriography

CO2 aortogram PROCEDURE

Standard of care

Also known as: Aortography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients must be affected by HCC
• Patients must have diminished renal function (GFR\<60 ml/min/1.73m\^2)
• Patients must be 18 years old or older
• Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Subjects under the age of 18
• Patients currently on dialysis
• Pregnant women

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Cerebral Angiography

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Nishita N. Kothary

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: March 30, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

US (1)