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

GE Healthcare304 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

304

Conditions

Patient Comfort and Safety

Interventions

IodixanolDRUG

Iodixanol 320 mg I/mL as a single iv. administration.

IopamidolDRUG

Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Within 10 minutes post contrast administration.

Secondary Outcomes

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.

Time frame: Ten minutes post contrast administration.

Data from ClinicalTrials.gov

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