Thoracoabdominal Arortic CTA Study

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02291718
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 20
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm	Drug: Isovue	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Isovue 300 75mL Isovue 300 75mL injected 120 kVp 250 mAs	Drug: Isovue; iodine contrast
Active Comparator: Isovue 370 75mL Isovue 370 75mL injected 100 kVp 240 mAs	Drug: Isovue; iodine contrast
Active Comparator: Isovue 370 60mL Isovue 370 60mL injected 100 kVp 240 mAs	Drug: Isovue; iodine contrast

Outcome Measures

Primary Outcome Measures

1. Radiation Dose [30 minutes]

Secondary Outcome Measures

1. 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.

2. 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.

3. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02291718
• Other Study ID Numbers: Pro00048275
• First Posted: Nov 14, 2014
• Last Update Posted: Apr 18, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Duke University: Suspected or confirmed; TAA; Computed tomography angiography; CTA; Contrast agent; Radiation dose; Thoracoabdominal aortic aneurysm
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic

Study Results

Participant Flow

Arm/Group Title	Isovue 300 (75mL)	Isovue 370 (75mL)	Isovue 370 (60mL)
Arm/Group Description	75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan	75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT	60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
Period Title: Overall Study
STARTED	50	50	50
COMPLETED	50	50	50
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Isovue 300 (75mL)	Isovue 370 (75mL)	Isovue 370 (60mL)	Total
Arm/Group Description	75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan	75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT	60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT	Total of all reporting groups
Overall Participants	50	50	50	150
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	21 42%	15 30%	14 28%	50 33.3%
>=65 years	29 58%	35 70%	36 72%	100 66.7%
Sex: Female, Male (Count of Participants)
Female	19 38%	19 38%	27 54%	65 43.3%
Male	31 62%	31 62%	23 46%	85 56.7%

Outcome Measures

1. Primary Outcome

Title	Radiation Dose
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isovue 300 75mL	Isovue 370 75mL	Isovue 370 60mL
Arm/Group Description	Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Measure Participants	50	50	50
Mean (Standard Deviation) [mSv]	35.1 (6.2)	25.4 (5.3)	25.5 (7.0)

2. Secondary Outcome

Title	Signal to Noise Ratio
Description	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.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

Hiatus region of each subject group

Arm/Group Title	Isovue 300 75mL	Isovue 370 75mL	Isovue 370 60mL
Arm/Group Description	Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Measure Participants	50	50	50
Mean (Standard Deviation) [Signal-to-Noise Ratio]	12.0 (4.8)	11.8 (3.5)	13.8 (6.3)

3. Secondary Outcome

Title	Hounsfield Unit Attenuation Values
Description	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.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isovue 300 75mL	Isovue 370 75mL	Isovue 370 60mL
Arm/Group Description	Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Measure Participants	50	50	50
Mean (Standard Deviation) [Hounsfield units]	289.7 (23.8)	400.9 (31.1)	393.9 (28.1)

4. Secondary Outcome

Title	Variation in Contrast for the Entire Vascular System (coV)
Description	The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isovue 300 75mL	Isovue 370 75mL	Isovue 370 60mL
Arm/Group Description	Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Measure Participants	50	50	50
Mean (Standard Deviation) [unitless]	0.113 (0.073)	0.124 (0.063)	0.107 (0.059)

Adverse Events

Arm/Group Title	Isovue 300 (75mL)		Isovue 370 (75mL)		Isovue 370 (60mL)
Arm/Group Description	75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan		75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT		60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
All Cause Mortality
	Isovue 300 (75mL)		Isovue 370 (75mL)		Isovue 370 (60mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Isovue 300 (75mL)		Isovue 370 (75mL)		Isovue 370 (60mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Isovue 300 (75mL)		Isovue 370 (75mL)		Isovue 370 (60mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.