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The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to routine, standard of care dose exams.
Any adult patient age 18 and above, scheduled for routine CTA (Computed Tomography Arteriograms) of the chest or chest, abdomen and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included in the study. The patient will be administered a low dose of intravenous contrast based on the study examination as described below.
CTA of the chest: 40 mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.
CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast (Omnipaque) at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.
Following the examination, the primary investigator (PI) or team members will evaluate the images obtained with low contrast dose and each patient's prior CTA examination performed with routine contrast dose, 100mL at a rate of 4mL/sec. This will be done by quantitative and qualitative measures. For the quantitative portion, the PI or team members will place regions of interest on predetermined arterial locations to obtain measure the degree of opacification. For qualitative measurement, the images will be presented in a blind fashion to two thoracic trained board certified radiologists and a board certified interventional radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and quantitative data for the images obtained with low contrast dose and those for the prior CTA examinations performed with routine contrast dose will be compared. This data along with details of the scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and BMI at the time of examination) will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Contrast (40mL) | Active Comparator | CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. |
|
| Low Dose Contrast (50mL) | Active Comparator | CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Contrast (Omnipaque) 40mL | Drug | The patient will be administered a low dose, 40mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec. |
| Measure | Description | Time Frame |
|---|---|---|
| Ascending Sinotubular Junction Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction. | At 30 days |
| Descending Thoracic Aorta Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation. | 30 days |
| Celiac Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis. | 30 days |
| Burfication Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation. | 30 days |
| Right Common Femoral Artery Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery. | 30 days |
| Left Common Femoral Artery Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26937437 | Background | Seehofnerova A, Kok M, Mihl C, Douwes D, Sailer A, Nijssen E, de Haan MJ, Wildberger JE, Das M. Feasibility of low contrast media volume in CT angiography of the aorta. Eur J Radiol Open. 2015 Apr 28;2:58-65. doi: 10.1016/j.ejro.2015.03.001. eCollection 2015. | |
| 12598026 | Background | Rubin GD. MDCT imaging of the aorta and peripheral vessels. Eur J Radiol. 2003 Mar;45 Suppl 1:S42-9. doi: 10.1016/s0720-048x(03)00036-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Contrast (Omnipaque) Low Dose (40mL) | CTA of the chest: 40 mL of intravenous contrast (omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast. |
| FG001 | Contrast (Omnipaque) Low Dose (50mL) | CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Contrast (40mL) | CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. |
| 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 | Ascending Sinotubular Junction Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction. | Ascending Sinotubular Junction Measurement was assessed for the following scans: Chest, Abdomen & Pelvis, and Chest, Abdomen, & Pelvis | Posted | Mean | Full Range | Hounsfield units | At 30 days |
|
30 days
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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 | Low Dose Contrast (40mL) | CTA of the chest: 40 mL of intravenous contrast (omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. . The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rekha Cherian, M.D. | Milton S. Hershey Medical Center | 717-531-6735 | rcherian@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2018 | Mar 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D003287 | Contrast Media |
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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|
| Low Dose Contrast (Omnipaque) 50 mL | Drug | The patient will be administered a low dose, 50mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec. |
|
| 30 days |
| CTA Vessel Opacification Grading 1 | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist.
| 30 days |
| CTA Vessel Opacification Grading 2 | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist.
| 30 days |
| 15547209 | Background | Gleeson TG, Bulugahapitiya S. Contrast-induced nephropathy. AJR Am J Roentgenol. 2004 Dec;183(6):1673-89. doi: 10.2214/ajr.183.6.01831673. No abstract available. |
| 26047631 | Background | Vanommeslaeghe F, De Mulder E, Van de Bruaene C, Van de Bruaene L, Lameire N, Van Biesen W. Selecting a strategy for prevention of contrast-induced nephropathy in clinical practice: an evaluation of different clinical practice guidelines using the AGREE tool. Nephrol Dial Transplant. 2015 Aug;30(8):1300-6. doi: 10.1093/ndt/gfv220. Epub 2015 Jun 4. |
| 16763513 | Background | Meschi M, Detrenis S, Musini S, Strada E, Savazzi G. Facts and fallacies concerning the prevention of contrast medium-induced nephropathy. Crit Care Med. 2006 Aug;34(8):2060-8. doi: 10.1097/01.CCM.0000227651.73500.BA. |
| 17291156 | Background | Walsh SR, Tang T, Gaunt ME, Boyle JR. Contrast-induced nephropathy. J Endovasc Ther. 2007 Feb;14(1):92-100. doi: 10.1583/06-2035.1. |
| 2010458 | Background | Gussenhoven MJ, Ravensbergen J, van Bockel JH, Feuth JD, Aarts JC. Renal dysfunction after angiography; a risk factor analysis in patients with peripheral vascular disease. J Cardiovasc Surg (Torino). 1991 Jan-Feb;32(1):81-6. |
| 18295101 | Background | Diehm N, Pena C, Benenati JF, Tsoukas AI, Katzen BT. Adequacy of an early arterial phase low-volume contrast protocol in 64-detector computed tomography angiography for aortoiliac aneurysms. J Vasc Surg. 2008 Mar;47(3):492-8. doi: 10.1016/j.jvs.2007.11.004. |
| 22683247 | Background | Viteri-Ramirez G, Garcia-Lallana A, Simon-Yarza I, Broncano J, Ferreira M, Pueyo JC, Villanueva A, Bastarrika G. Low radiation and low-contrast dose pulmonary CT angiography: Comparison of 80 kVp/60 ml and 100 kVp/80 ml protocols. Clin Radiol. 2012 Sep;67(9):833-9. doi: 10.1016/j.crad.2011.11.016. Epub 2012 Jun 8. |
| 23169715 | Background | Wu CC, Lee EW, Suh RD, Levine BS, Barack BM. Pulmonary 64-MDCT angiography with 30 mL of IV contrast material: vascular enhancement and image quality. AJR Am J Roentgenol. 2012 Dec;199(6):1247-51. doi: 10.2214/AJR.12.8739. |
| BG001 | Low Dose Contrast (50mL) | CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Scan | Count of Participants | Participants |
|
| Contrast, 100mL: Scan Dose | Count of Participants | Participants |
|
| Contrast, 100mL: Ascending: Sinotubular Junction Measurement | Mean | Full Range | hounsfield units |
|
| Contrast, 100mL: Descending: Pulmonary Artery Measurement | Mean | Full Range | hounsfield units |
|
| Contrast, 100mL: Celiac Measurement | Mean | Full Range | hounsfield units |
|
| Contrast, 100mL: Bifurcation Measurement | Mean | Full Range | hounsfield units |
|
| Contrast, 100mL: Right Common Femoral Measurement | Mean | Full Range | hounsfield units |
|
| Contrast, 100mL: Left Common Femoral Measurement | Mean | Full Range | hounsfield units |
|
| Contrast, 100mL: CTA Vessel Opacification Grading 1 | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist.
| Mean | Full Range | score on a scale |
|
| Contrast, 100mL: CTA Vessel Opacification Grading 2 | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist.
| Mean | Full Range | score on a scale |
|
| OG001 | Contrast (Omnipaque) Low Dose (50mL) | CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast. |
|
|
| Primary | Descending Thoracic Aorta Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation. | Descending Thoracic Aorta Measurement was assessed for the following scans: Chest, and Chest, Abdomen, & Pelvis | Posted | Mean | Full Range | Hounsfield units | 30 days |
|
|
|
| Primary | Celiac Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis. | Celiac Measurement was assessed for all scans: Chest, Abdomen, Abdomen & Pelvis, and Chest, Abdomen, & Pelvis. | Posted | Mean | Full Range | Hounsfield units | 30 days |
|
|
|
| Primary | Burfication Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation. | Burfication measurements were taken from the following scans: Abdomen, Abdomen & Pelvis, and Chest, Abdomen, & Pelvis. | Posted | Mean | Full Range | Hounsfield units | 30 days |
|
|
|
| Primary | Right Common Femoral Artery Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery. | All participants in the Contrast (Omnipaque) Low dose (40mL) underwent only a CTA of the chest or abdomen which is incapable of measuring the right common femoral artery. | Posted | Mean | Full Range | Hounsfield units | 30 days |
|
|
|
| Primary | Left Common Femoral Artery Measurement | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery. | All participants in the Contrast (Omnipaque) Low dose (40mL) underwent only a CTA of the chest or abdomen which is incapable of measuring the Left common femoral artery | Posted | Mean | Full Range | Hounsfield units | 30 days |
|
|
|
| Primary | CTA Vessel Opacification Grading 1 | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist.
| Posted | Mean | Full Range | score on a scale | 30 days |
|
|
|
| Primary | CTA Vessel Opacification Grading 2 | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist.
| Posted | Mean | Full Range | score on a scale | 30 days |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Low Dose Contrast (50mL) | CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Abdomen and Pelvis Scan |
|
| Chest, Abdomen, and Pelvis Scan |
|
| Chest and Abdomen Scan |
|