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OpenTrials
Completed

NCT Number: NCT00926536

Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance

Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be randomized to one of two arms for imaging navigation to the optimal catheter location for chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be: TACE using C-arm CT supplemented by DSA or DSA only (only DSA images will be used for navigation and tumor vessel tracking). Navigation to subsequent treatment targets in all patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford University Medical Center, and is not part of the study. Vascular complexity, which affects navigation difficulty and thus the need for imaging, will be assessed separately for use in data analysis by two radiologists on a four-point scale.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

We hope to learn more about the utility of C-arm CT in patients undergoing TACE for HCC. Data will be evaluated with regards to:

  • Sensitivity and specificity to diagnose additional tumors and its impact on transplantation criteria.
  • The ability to decrease procedural time by aiding navigation through complex arterial anatomy.
  • Impact on radiation dose. Although the patient would receive the radiation during C-arm CT, overall the number of DSA angiograms and fluroscopy may decrease, potentially negating any effect of the additional dose from C-arm CT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must be affected by HCC

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.

Exclusion criteria

Subjects under the age of 18

Pregnant women

Treatment and study plan

C-arm CT + DSA as needed

Device

C-arm CT images obtained and supplemented with DSA if needed

Other names: x-ray image intensifier, C-arm CT

DSA only

Device

DSA imaging only

Other names: Standard of care

Primary outcomes

  1. Dose Area Product (DAP)

    Time frame: Duration of a TACE procedure, an average of 2 hours

    Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)

  2. Cumulative Dose (CD), a Measure of Radiation Dose

    Time frame: Duration of a TACE procedure, an average of 2 hours

    CD - a measurement of total radiation to the skin (measure of a deterministic dose)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Siemens Healthcare Diagnostics Inc

Registry information

Official study title

Impact of C-arm CT in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transhepatic Arterial Chemoembolization (TACE): Optimal Imaging Guidance

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2009
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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