A DOUBLE-BLIND INTER-INDIVIDUAL COMPARISON OF IOMEPROL 300 AND IOMEPROL 400 IN THE ASSESSMENT OF PERFUSION CT OF ADVANCED RENAL CARCINOMA - Perfusion CT of Renal Carcinoma

Bracco Imaging Deutschland GmbH0 个研究点目标入组 60 人开始时间: 2006年9月21日最近更新: 2012年3月19日

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•1. Renal carcinoma with at least one abdominal mass (if possible at the kidney level) larger than 2 cm (largest axial diameter);
•2. Indication for Computed Tomography due to re-staging before the start of a new antiangiogenic treatment;
•3. Patient is >= 35 years old, conscious and co-operative;
•4. Written Informed Consent to participate in the study.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Hyperthyroidism (TSH below 0.3 mU/L);
•2. Renal insufficiency (serum creatinine > 1.5 mg/dL);
•3. Hypersensitivity to iodinated contrast media or significant allergic disposition;
•4. Insulin-dependent diabetes mellitus or metformin medication (discontinuation for 48 h enables CT examination of patients with normal renal function);
•5. Acute stroke;
•6. Known epilepsy that is currently active;
•7. Planned radioactive iodine therapy;
•8. Participation in a clinical trial within the past 30 days;
•9. Previous participation in this clinical trial;
•10. Alcohol or drug abuse;
•11. Patient is female and pregnant or nursing;
•12. Patient is female and the possibility of pregnancy cannot be excluded by one of the following methods:
•- surgical sterilization (method has to be recorded on medical history form),
•- confirmed post-menopausal (with minimum 1-year history without menstruation),
•- negative pregnancy test (confirmed via ß-HCG measurement);
•13. Patient is institutionalized by law;
•14. Circumstances that would significantly decrease the chance of obtaining reliable data or of achieving the study objectives according to the Investigator’s final opinion
•15. Inadequate peripheral veins, which would not allow for the required fast administration of contrast agent (via 18 gauge needle).

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