multiple myeloma, Waldenstrom disease o MGUS and lung cancer patients (control group MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: VISIPAQUE*320MG I/ML FL 500ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iodixanol
CAS Number: 92339-11-2
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with multiple myeloma, Waldenstrom disease o MGUS and lung cancer patients (control group 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: age less than 18 or greater than 71. renal function impairment (SCr > 1.5 mg/dL for women and > 1.7 for men. diabetes. intolerance to iodine containing contrast media. concomitant treatment with nephrotoxic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the effect on renal function of i.v. Visipaque administration and to define the suitability and relative risk of CT scan examination which is necessary for the staging of these patients appropriatness;Secondary Objective: none;Primary end point(s): renal function impairment evaluated through NAG escretion 24 hours after the administration of the contrast media; livelli di Creatinina serica 72 ore dopo la somministrazione del contrasto; Clearance della Creatinina 72 ore dopo l'assunzione di contrasto | — |
Countries
Italy
Outcome results
None listed