NCT02291718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 24, 2017

Completed
Last Updated

April 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

October 23, 2014

Results QC Date

September 28, 2016

Last Update Submit

March 22, 2017

Conditions

Thoracic Aortic Aneurysm

Keywords

Suspected or confirmedTAAComputed tomography angiographyCTAContrast agentRadiation doseThoracoabdominal aortic aneurysm

Outcome Measures

Primary Outcomes (1)

  • Radiation Dose

    30 minutes

Secondary Outcomes (3)

  • Signal to Noise Ratio

    30 minutes

  • Hounsfield Unit Attenuation Values

    30 minutes

  • Variation in Contrast for the Entire Vascular System (coV)

    30 minutes

Study Arms (3)

Isovue 300 75mL

ACTIVE COMPARATOR

Isovue 300 75mL injected 120 kVp 250 mAs

Drug: Isovue

Isovue 370 75mL

ACTIVE COMPARATOR

Isovue 370 75mL injected 100 kVp 240 mAs

Drug: Isovue

Isovue 370 60mL

ACTIVE COMPARATOR

Isovue 370 60mL injected 100 kVp 240 mAs

Drug: Isovue

Interventions

IsovueDRUG

iodine contrast

Isovue 300 75mLIsovue 370 60mLIsovue 370 75mL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing thoracoabdominal aortic (TAA) CTA
  • Able to provide informed consent
  • Body Mass Index (BMI) equal to or less than 30

You may not qualify if:

  • Creatinine greater than 2.0
  • Allergy to contrast media
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAortic Aneurysm, Thoracoabdominal

Interventions

Iopamidol

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAortic Aneurysm, Abdominal

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Dr. Lynne Koweek
Organization
Duke University Medical Center
lynne.koweek@duke.edu
919-684-8111

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 14, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 18, 2017

Results First Posted

February 24, 2017

Record last verified: 2017-01

Locations

US(1)