Comparison of High Iodine Concentration Contrast Material (Isovue 370) vs Standard Protocol (Isovue 300) in Thoracoabdominal Aortic Computed Tomographic Angiography (CTA) for Radiation Dose Reduction
| Registry | NCT02291718 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; non randomized, parallel, masking: none, other |
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| Enrollment | 150 (Actual) |
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| Sponsor | Duke University (Other) |
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| Conditions | Thoracic Aortic Aneurysm |
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| Interventions | Isovue (Drug) |
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| Dates | start 2014-01-01, primary completion 2015-09-01, completion 2015-09-01, first posted 2014-11-14, last updated 2017-04-18 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Thoracic Aortic Aneurysm All trials of Isovue
-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Isovue 300 75mL | Active comparator | Drug: Isovue | Isovue 300 75mL injected 120 kVp 250 mAs |
| Isovue 370 75mL | Active comparator | Drug: Isovue | Isovue 370 75mL injected 100 kVp 240 mAs |
| Isovue 370 60mL | Active comparator | Drug: Isovue | Isovue 370 60mL injected 100 kVp 240 mAs |
- Isovue (Drug): iodine contrast
+Outcome measures
Primary outcomes
- Radiation Dose [30 minutes]
Secondary outcomes
- Signal to Noise Ratio [30 minutes]: 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.
- Hounsfield Unit Attenuation Values [30 minutes]: 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.
- Variation in Contrast for the Entire Vascular System (coV) [30 minutes]: The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Patients undergoing thoracoabdominal aortic (TAA) CTA
* Able to provide informed consent
* Body Mass Index (BMI) equal to or less than 30
Exclusion Criteria:
* Creatinine greater than 2.0
* Allergy to contrast media
* Pregnant women
+Posted results
Participant flow
| Milestone | Isovue 300 (75mL) | Isovue 370 (75mL) | Isovue 370 (60mL) |
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| Started | 50 | 50 | 50 |
| Completed | 50 | 50 | 50 |
| Not completed | 0 | 0 | 0 |
Outcome results
- Radiation Dose (Primary), Mean, mSv: Isovue 300 75mL 35.1 +/- 6.2; Isovue 370 75mL 25.4 +/- 5.3; Isovue 370 60mL 25.5 +/- 7.0
- Signal to Noise Ratio (Secondary), Mean, Signal-to-Noise Ratio: Isovue 300 75mL 12.0 +/- 4.8; Isovue 370 75mL 11.8 +/- 3.5; Isovue 370 60mL 13.8 +/- 6.3
- Hounsfield Unit Attenuation Values (Secondary), Mean, Hounsfield units: Isovue 300 75mL 289.7 +/- 23.8; Isovue 370 75mL 400.9 +/- 31.1; Isovue 370 60mL 393.9 +/- 28.1
- Variation in Contrast for the Entire Vascular System (coV) (Secondary), Mean, unitless: Isovue 300 75mL 0.113 +/- 0.073; Isovue 370 75mL 0.124 +/- 0.063; Isovue 370 60mL 0.107 +/- 0.059
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Isovue 300 (75mL) | 0 | 0/50 (0.0%) | 0/50 (0.0%) |
| Isovue 370 (75mL) | 0 | 0/50 (0.0%) | 0/50 (0.0%) |
| Isovue 370 (60mL) | 0 | 0/50 (0.0%) | 0/50 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| Duke University Medical Center | Durham, North Carolina | United States | |