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| ID | Type | Description | Link |
|---|---|---|---|
| SU-05122009-2518 | Other Identifier | Stanford University | |
| HEP0020 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| Siemens Healthcare Diagnostics Inc | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-arm CT + DSA as needed' | Experimental | 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. |
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| DSA only | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-arm CT + DSA as needed | Device | C-arm CT images obtained and supplemented with DSA if needed |
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| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Rebecca Fahrig | Stanford University | Principal Investigator |
| Nishita N. Kothary | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | C-arm CT +DSA as Needed | C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation |
| FG001 | DSA Only | Only Digital subtraction images used for vessel tracking and tumor navigation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only patients completing the study are represented here. The three patients that were excluded by the physician is because the patients disease had progressed by the time of the study
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| ID | Title | Description |
|---|---|---|
| BG000 | C-arm CT + DSA as Needed | C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking |
| BG001 | DSA Only | DSA images only used for vessel navigation and tracking |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | DAP measured in both groups | Posted | Mean | Full Range | Gy.cm2 | Duration of a TACE procedure, an average of 2 hours |
|
The duration of the procedure, since this was an imaging study. TACE procedures are an average of 2 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C-arm CT + DSA as Needed | C-arm CT used for the purposes of navigation, supplemented by DSA if needed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Hematoma | Surgical and medical procedures | Non-systematic Assessment |
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This is an imaging study looking at two different modalities of imaging. There is no long term follow up or A/Es associated with this type of a study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nishita Kothary | Stanford University | 6504986020 | kothary@stanford.edu |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| DSA only | Device | DSA imaging only |
|
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| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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|
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| Primary | Cumulative Dose (CD), a Measure of Radiation Dose | CD - a measurement of total radiation to the skin (measure of a deterministic dose) | CD measured in both groups | Posted | Mean | Full Range | mGy | Duration of a TACE procedure, an average of 2 hours |
|
|
|
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| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | DSA Only | DSA only used for navigation | 1 | 41 | 0 | 41 |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |