drugset / Trial / NCT02433665

Customized Contrast Media Dose Clinical Trial

NCT02433665

RandomizedParallel-groupOpen-labelDiagnostic

Summary

1. To determine if a formula derived from PCA using specific patient parameters can be used to determine the individual contrast material dose and provide a more consistent level of vascular and parenchymal enhancement during MDCT scanning of the abdomen and pelvis. 2. Up to 500 adult patients referred for a "CT of the abdomen and pelvis with contrast material" will be recruited to participate in this trial. Single CT axial slices (n=2) will be obtained at the level of the L4 pedicle and the supra-acetabular pelvis using a field-of-view that includes all of the patient. From patient measurements (height, weight, body dimensions), a customized dose of contrast material will be specified according to the derived formula for 400 subjects. One hundred subjects will receive the usual fixed contrast dose. 3. Enhancement data in HU will be measured from the CT scans using manually-placed ROIs on the upper abdominal aorta, main portal vein and liver parenchyma, avoiding visible liver tumors, major blood vessels and artifacts, if present. This enhancement data will be used to determine the patient-to-patient variability.

Timeline

Start
2015-08
Primary completion
2016-10-06
Completion
2016-10-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iopamidol Diagnostic / imaging agent 75 ml Intravenous
Comparator Iopamidol Diagnostic / imaging agent 150 ml Intravenous
Comparator Iopamidol Diagnostic / imaging agent 200 ml Intravenous

Indications

No indication recorded.