Oncological patients undergoing to diagnostic imaging MedDRA version: 9.1 Level: HLGT Classification code 10022893
Conditions
Interventions
Trade Name: VISIPAQUE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iodixanol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 320-
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age at recruitment in an 18 to 70 year range • Histologically confirmed cancer diagnosis: we will recruit patients who had received a histologically confirmed cancer diagnosis within a 5-year interval prior to the study entry (prevalent cases) as well as patients diagnosed with any incident, histologically confirmed cancer (incident cases). We will include cancer patients independent of the primitive cancer site (also considering cancers of unknown origin), histological type, stage and grade of cell anaplasia. • Very low risk of CIN: we will include cancer patients at very low risk of CIN as defined by a GFR >60 ml/min. To join our study, the GFR assessment has to take place within the 72 hours preceding the CT scan • Prior indication to a thorax-abdomen-pelvis CT scan with iodine CM: we will include cancer patients with a pre-scheduled thorax-abdomen-pelvis CT scan assessment, whose indications are totally independent from our study purposes 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: • Pathological conditions: o diabetes mellitus (both IDDM and NIDDM) o cardio/cerebro-vascular diseases: coronary artery disease, myocardial infarction, uncontrolled/untreated hypertension (that is, a diastolic/systolic blood pressure equal to or greater than 100/140 mm Hg) o sepsis o multi/polycystic kidney o solitary kidney o acquired immune-deficiency syndrome (AIDS) • Previous transplants (any indication, any site) • Dehydration or reduction of plasmatic volume (based on the hematocric value) • Iodated contrast-media administration in the last 30 days before the exam • History of CM hypersensitiveness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: CIN development in participants randomized to either iodixanol (iso-osmolar CM) or iopromide (low-osmolar CM);Secondary Objective: Development of irreversible CIN (namely, at least a 15 day-persistent CIN) Average GFR percentage variation between the two study groups Any short-, long-term adverse events related to CM use;Primary end point(s): Frequency of CIN cases will be assessed based on a decrease of baseline GFR> 25%. | — |
Countries
Italy
Outcome results
None listed