subjects with mild to moderate renal impairment scheduled to undergo clinically-indicated IV contrast –enhanced MDCT scanning of the liver
Conditions
Sponsors
Bracco Imaging S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Provide written Informed Consent and are willing to comply with protocol requirements • 18 years of age or older, • have a stable* baseline serum creatinine level of SCr =1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min. *2 stable values: one within 6 months and one within 2 weeks before the examination, • referred for a clinically-indicated contrast-enhanced MDCT examination of the liver 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
Exclusion criteria
Exclusion criteria: • determined, by their physicians, that prophylactic medication is medically required for them to receive intravascular administration of an iodinated contrast agent, • a history of hypersensitivity to iodine-containing compounds, • severe congestive heart failure (class III-IV NYHA), • suspicion of hyperthyroidism or thyroid malignancies, • undergone or is scheduled to undergo any other radiological procedure utilizing x-ray contrast media from 72 hours before to 7 days after the administration of the study agent, • uncontrolled diabetes, • dialysis, • unstable renal function / serum creatinine levels/acute renal failure, • is a pregnant or lactating female. Exclude the possibility of pregnancy by testing on site at the institution (serum or urine ßHCG) within 72 hours prior to the start of study agent administration - by history (tubal ligation or hysterectomy) - post menopausal with a minimum 1 year without menses (time of pregnancy test in relation to study agent administration must be recorded); • previously entered in this study or received an investigational compound within 30 days prior to admission to this study, • any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or achieving post dose follow-up examinations i.e.: • drug dependence, • psychiatric disorders, dementia, or other reasons for expected poor compliance with investigator’s instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To quantitatively compare the efficacy of arterial phase and portal venous phase enhancement of key vessels and normal liver parenchyma in subjects with mild to moderate renal impairment (SCr =1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min) who undergo clinically-indicated IV contrast-enhanced MDCT scanning of the liver with equi-iodine doses of one of two contrast agents: Visipaque™320 or Iomeron®-400.;Secondary Objective: • To qualitatively compare the efficacy of arterial phase and portal venous phase scans in subjects with mild to moderate renal impairment, who undergo clinically-indicated IV contrast-enhanced MDCT scanning of the liver with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™ 320. • To quantitatively compare between the two study agents the maximum differentiation of enhancement (expressed as a ‘delta’, which may be positive or negative in value) of focal liver lesions (if present) vs. adjacent normal liver parenchyma. • To compare between the two study agents the incidence of contrast-induced nephropathy (CIN), defined as a >0.5 mg/dL post-CT scan increase in serum creatinine at 48-72 hours post-dose. • To compare between the two study agents the incidence of delayed (2 hours to 7 days post-administration) hypersensitivity-type cutaneous/subcutaneous adverse reactions. ;Primary end point(s): To quantitatively compare the efficacy of arterial phase and portal venous phase enhancement of key vessels and normal liver parenchyma during IV contrast-enhanced MDCT scanning of the liver with equi-iodine doses of either ISOVUE or VISIPAQUE. The quantitative measurements of maximum CT density in HU, after contrast administration will be analyzed by means of the Student’s t test for unpaired data. A separate analysis will be carried out for each of the three off-site blinded readers. | — |
Countries
Austria, Italy, Sweden, United Kingdom
Outcome results
None listed