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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis

Conditions
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Patient Comfort and Safety

Intervention / Treatment
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* Drug: Iodixanol
* Drug: Iopamidol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1-Iodixanol<br> | Drug: Iodixanol<br>* Iodixanol 320 mg I/mL as a single iv. administration.<br>* Other names: Visipaque;|
| Active Comparator: Arm 2-Iopamidol<br> | Drug: Iopamidol<br>* Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.<br>* Other names: Isovue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 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. | Within 10 minutes post contrast administration | 
| Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 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. | Within 10 minutes post contrast administration. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety