Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study

Aortic Aneurysm Clinical Trial

Official title:

Does Reduction in Contrast Administration Dose in Computed Tomography Arteriograms Degrade Image Quality? A Single Institutional Review of an Ultra-low Contrast Dose Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669784
• Other study ID #: 3932
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2018

Study information

• Verified date: May 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or chest, abdomen and pelvis who had undergone a prior CTA performed with the standard contrast dose (100 mL) at this institution will be included in the study

• The follow-up scan will be routine standard of care, no emergency imaging patient will be approached for this research

Exclusion Criteria:

• Patients with no prior CTA imaging for comparison

• Any pediatric patient (age <18)

• BMI >40

• Inability to follow instructions

• Allergy to intravenous contrast

• GFR less than 30 mL/min/1.73 m2

Related Conditions & MeSH terms

• Aneurysm
• Aortic and Arterial Anomalies
• Aortic Aneurysm
• Contrast Induced Nephropathy

Intervention

Drug:
• Low Dose Contrast (Omnipaque) 40mL
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.
• Low Dose Contrast (Omnipaque) 50 mL
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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Gleeson TG, Bulugahapitiya S. Contrast-induced nephropathy. AJR Am J Roentgenol. 2004 Dec;183(6):1673-89. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Rubin GD. MDCT imaging of the aorta and peripheral vessels. Eur J Radiol. 2003 Mar;45 Suppl 1:S42-9. Review. — View Citation

Seehofnerová 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. — View Citation

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. — View Citation

Viteri-Ramírez G, García-Lallana A, Simón-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. — View Citation

Walsh SR, Tang T, Gaunt ME, Boyle JR. Contrast-induced nephropathy. J Endovasc Ther. 2007 Feb;14(1):92-100. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At 30 days
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.	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.	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.	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.	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.	30 days
Primary	CTA Vessel Opacification Grading 1	5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist.; Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic.; Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic.; Moderate opacification of the lumen of the vessel. Diagnostic study.; Good opacification of the lumen of the vessel.; Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.	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.; Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic.; Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic.; Moderate opacification of the lumen of the vessel. Diagnostic; Good opacification of the lumen of the vessel.; Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.	30 days