Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis

Phase 4

Completed

• Conditions: Patient Comfort and Safety
• Interventions: Drug: Iodixanol; Drug: Iopamidol

• Registration Number: NCT01376089
• Lead Sponsor: GE Healthcare

Brief Summary

The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2011-10
• Study Completion: 2012-02
• Results First Submitted: 2013-05-30
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-05
• Last Update Submitted: 2013-11-05
• Results First Posted: 2013-12-19
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• The subject is over 18 years old.
• Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their routine clinical care.

Exclusion Criteria

• The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
• The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
• The subject is pregnant.
• The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
• The subject manifests thyrotoxicosis or is on dialysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1-Iodixanol	Iodixanol	-
Arm 2-Iopamidol	Iopamidol	-

Primary Outcome Measures

Name	Time	Method
Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.	Within 10 minutes post contrast administration	Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.	Within 10 minutes post contrast administration.	Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.

Secondary Outcome Measures

Name	Time	Method
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.	Ten minutes post contrast administration.	Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States