Carcinoma, Hepatocellular
Conditions
Brief summary
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
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
Interventions
DEVICEC-arm CT + DSA as needed
C-arm CT images obtained and supplemented with DSA if needed
DEVICEDSA only
DSA imaging only
Sponsors
Siemens Healthcare Diagnostics Inc
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Area Product (DAP) | 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) |
| Cumulative Dose (CD), a Measure of Radiation Dose | Duration of a TACE procedure, an average of 2 hours | CD - a measurement of total radiation to the skin (measure of a deterministic dose) |
Countries
United States
Participant flow
Recruitment details
Study was open from 01/13/2009 thru 10/13/2010. During this period, subjects with HCC who were scheduled to undergo TACE were approached for permission to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| C-arm CT + DSA as Needed C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking | 43 |
| DSA Only DSA images only used for vessel navigation and tracking | 41 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 2 |
Baseline characteristics
| Characteristic | C-arm CT + DSA as Needed | DSA Only | Total |
|---|---|---|---|
| Age, Customized <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized Over 18 years old | 43 participants | 41 participants | 84 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Male | 37 Participants | 29 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 41 |
| serious Total, serious adverse events | 0 / 43 | 1 / 41 |
Outcome results
Primary
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
Population: CD measured in both groups
| Arm | Measure | Value (MEAN) |
|---|---|---|
| C-arm CT +DSA as Needed | Cumulative Dose (CD), a Measure of Radiation Dose | 626.4 mGy |
| DSA Only | Cumulative Dose (CD), a Measure of Radiation Dose | 784.7 mGy |
p-value: 0.017Mixed Models Analysis
Primary
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
Population: DAP measured in both groups
| Arm | Measure | Value (MEAN) |
|---|---|---|
| C-arm CT +DSA as Needed | Dose Area Product (DAP) | 184.2 Gy.cm2 |
| DSA Only | Dose Area Product (DAP) | 137.4 Gy.cm2 |
p-value: <0.001Mixed Models Analysis