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The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations. If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isovue 300 75mL | Active Comparator | Isovue 300 75mL injected 120 kVp 250 mAs |
|
| Isovue 370 75mL | Active Comparator | Isovue 370 75mL injected 100 kVp 240 mAs |
|
| Isovue 370 60mL | Active Comparator | Isovue 370 60mL injected 100 kVp 240 mAs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isovue | Drug | iodine contrast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Dose | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Signal to Noise Ratio | Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta. | 30 minutes |
| Hounsfield Unit Attenuation Values |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Isovue 300 (75mL) | 75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan |
| FG001 | Isovue 370 (75mL) | 75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT |
| FG002 | Isovue 370 (60mL) | 60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Isovue 300 (75mL) | 75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan |
| BG001 | Isovue 370 (75mL) | 75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Radiation Dose | Posted | Mean | Standard Deviation | mSv | 30 minutes |
|
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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 | Isovue 300 (75mL) | 75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lynne Koweek | Duke University Medical Center | 919-684-8111 | lynne.koweek@duke.edu |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.
| 30 minutes |
| Variation in Contrast for the Entire Vascular System (coV) | The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject. | 30 minutes |
| BG002 | Isovue 370 (60mL) | 60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Signal to Noise Ratio | Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta. | Hiatus region of each subject group | Posted | Mean | Standard Deviation | Signal-to-Noise Ratio | 30 minutes |
|
|
|
| Secondary | Hounsfield Unit Attenuation Values | Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements. | Posted | Mean | Standard Deviation | Hounsfield units | 30 minutes |
|
|
|
| Secondary | Variation in Contrast for the Entire Vascular System (coV) | The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject. | Posted | Mean | Standard Deviation | unitless | 30 minutes |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Isovue 370 (75mL) | 75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT | 0 | 50 | 0 | 50 |
| EG002 | Isovue 370 (60mL) | 60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT | 0 | 50 | 0 | 50 |
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| D001018 |
| Aortic Diseases |
| D017544 | Aortic Aneurysm, Abdominal |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |