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

Stanford University84 enrolled

Overview

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.

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: 1. Sensitivity and specificity to diagnose additional tumors and its impact on transplantation criteria. 2. The ability to decrease procedural time by aiding navigation through complex arterial anatomy. 3. 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

C-arm CT + DSA as neededDEVICE

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

DSA onlyDEVICE

DSA imaging only

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.