Isotonic contrast (iodixanol) administration vs. low osmolar contrast (iopromide) use: evaluating risk of contrast-induced nephropathy in cancer patients at very low risk - COMEDIANS

• Conditions: Oncological patients undergoing to diagnostic imaging; MedDRA version: 9.1Level: HLGTClassification code 10022893

• Registration Number: EUCTR2010-019740-39-IT
• Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

•Pathological conditions:
odiabetes mellitus (both IDDM and NIDDM)
ocardio/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)
osepsis
omulti/polycystic kidney
osolitary kidney
oacquired 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>Average GFR percentage variation between the two study groups<br>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%.