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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Device: C-arm CT + DSA as needed
* Device: DSA only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-arm CT + DSA as needed'<br>In the group of subjects randomized in this group, the image guidance component of the procedure will be conducted by the acquisition of 3D CT-like images during a trans-hepatic arterial injection of iodinated contrast agent for road mapping the tumor feeding vessels and supplemented by DSA as needed by the operating physician as imaging guidance for planning tumor(s) treatment approach. | Device: C-arm CT + DSA as needed<br>* C-arm CT images obtained and supplemented with DSA if needed<br>* Other names: C-arm CT;|
| Active Comparator: DSA only<br>In the group of subjects randomized in this group, present standard of care, i.e DSA imaging only will be used by the operating physician to map out the tumor vessels and used for treatment approach. Additional 3D CT-like images will be obtained, but only used if the operator cannot perform adequate planning using DSA alone. | Device: DSA only<br>* DSA imaging only<br>* Other names: Standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Area Product (DAP) | 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) | Duration of a TACE procedure, an average of 2 hours | 
| Cumulative Dose (CD), a Measure of Radiation Dose | CD - a measurement of total radiation to the skin (measure of a deterministic dose) | Duration of a TACE procedure, an average of 2 hours |