This is a multicenter oen label study that will be conducted in patients 65 years of age and older requiring body computed tomography for diagnostic purposes, pre-operative evaluation, or post-operative evaluation. The areas to be examined will be the head, neck, thorax, abdomen, and/or pelvis. Patients will receive a single intravenous administration of Iomeprol 400 mgI/mL to assess the pharmockinetics, safety, and efficacy of this contrast agent. Approximately 20 patients will be enrolled in the study. Approximately 3 sites will enroll a minimum of 5 and up to a maximum of 15 patients. The method of sample size determination for the study can be dfound in the Statistical Analysis plan (Appendix K). Only patients meeting the eligibility criteria for this protocol will b eadmitted to this study. Study patients, if not currently inpatients, will b ehospitalized or stay in a speical study unit for 14 hours prior to dosing until 72 hours after dosing. A complete physical examination will be performed within 24 hours pre-dose and at 24 and 72 hours post-dose. Supine systolic and diastolic blood pressure, pulse rate, and respiratory rate will be recorded at the following time points: 15 and 10 munutes pre-dose, at 10, 30, and 60 minutes and 2, 4, 24, and 72 hours post-dose. Body temperature (0C), will be recorded at 15 and 10 minutes pre-dose, and at 1, 4, 24, and 72 hours post-dose. A 12-lead ECG will be taken and recorded within 24 hours pre-dose and 24 and 72 hours post-dose. Blood will be withdrawn, either by venipuncture or through an indwelling catheter, from a suitable periopheral vein. Blood draws of approximately 1 ml in volume will be collected to obtain Iomeprol levels in plasma at 5 minutes pre-dose and 5, 15, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours after completion of dosing. In addition, within 24 hours prior to dosing and 24 and 72 hours post-dose patients will also have blood taken for chemistry and hematology. The total blood volume withdrawn during the protocol period should not exceed approximately 30 mL. Urine will be collected at 12 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 16, 16 to 24, 24 to 36, 36 to 48, 48 to 60, and 60 to 72 hours post-dose.
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