Patients undergoing CECT imaging of the abdomen/pelvis as part of their routine medical care. MedDRA version: 13.1 Level: PT Classification code 10022086 Term: Injection site pain System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 13.1 Level: PT Classification code 10013082 Term: Discomfort System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 13.1 Level: PT Classification code 10003051 Term: Applic
Conditions
Interventions
Trade Name: Visipaque™
Product Name: Visipaque 320 mg I/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IODIXANOL
CAS Number: 92339112
Concentration unit: mg/ml milligram(s)/milli
Sponsors
GE Healthcare Ltd. and its affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
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. -The subject has provided signed and dated informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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. Note: Metformin must not be taken at least 24 hours prior to the study procedures, withheld for at least 48 hours post-procedure, and restarted only after the subjects renal function has been evaluated and it is deemed safe to resume metformin. -The subject manifests thyrotoxicosis or is on dialysis. -The subject was previously included in this study. -The subject has unstable clinical condition where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 CECT imaging of the abdomen/pelvis.;Secondary Objective: To evaluate and compare the impact of patient discomfort on image procedure and overall image quality and to evaluate and compare the overall safety profile in terms of occurrence of adverse events. ;Primary end point(s): The primary safety endpoint is the comparison of the maximum intensity of patient discomfort between iodixanol 320 mg I/mL and iopamidol 370 mg I/mL as rated by the subjects within 10 minutes of intravenous contrast administration for their CECT imaging of the abdomen/pelvis. Patient discomfort includes sensations of coldness, heat or pain. The subject will be asked to separately rate the maximum intensity of the sensations of pain, warmth and coldness on a scale of 0-10 following the main bolus injection of CM and completion of the CT scan. The maximum intensity of patient discomfort score for each type will be converted into 4 categories: none = 0; mild= 1-3, Moderate = 4-7; severe = 8-10. The overall patient discomfort is defined as the maximum intensity of any individual discomfort score (i.e. pain, warmth or coldness). ;Timepoint(s) of evaluation of this end point: 10 minutes after intravenous injection of contast agent | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -To evaluate and compare the impact of image discomfort on image procedure and overall image quality -To evaluate and compare the overall safety profile in terms of occurrence of adverse events;Timepoint(s) of evaluation of this end point: Adverse events are followed up for 24 hours | — |
Countries
Germany, United States
Contacts
Public ContactAnne Juelsrud
GE Healthcare Ltd. and its affiliates
Outcome results
None listed