A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications

Phase 4

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: Xenetix; Drug: Visipaque

• Registration Number: NCT00347022
• Lead Sponsor: Guerbet

Brief Summary

This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Results First Submitted: 2011-12-23
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-08
• Last Update Submitted: 2013-04-08
• Results First Posted: 2013-04-09
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Child aged 1 year or above and 16 years or under
• Patients with normal renal function (creatinine clearance > 60 ml/min/1.73 m2)
• Patient requiring MSCT with contrast medium injection for diagnosis
• Patient who has a blood sample planned in the 24 hours preceding the MSCT scan
• Female patient with childbearing potential must have effective contraception (contraceptive pill or intrauterine device), be surgically sterilized or blood beta human chorionic gonadotropin (ßHCG) will be tested prior to product injection.
• Parent(s) of the patient (and child with sufficient intellectual maturity) provided his/her/their written informed consent for their child to participate in the trial.
• Patient with national health insurance

Exclusion Criteria

• Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
• Patient with known allergy to iodinated contrast agent.
• Patient treated with nephrotoxic drugs within one week before first blood sample
• Patients planned to either undergo surgery or receive chemotherapy within 72 hours post injection (ie: before the blood test 72 hours post injection)
• Patient received or planned to receive an iodinated contrast agent during 48 hours preceding the MSCT scan.
• Breast feeding patient.
• Pregnant patient.
• Patient already included in this trial
• Patient included in another clinical trial involving an investigational drug.
• Patients whose degree of cooperation is incompatible with carrying out the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenetix	Xenetix	The patient receive one injection of Xenetix 300 (300 mg of iodine/ml)
Visipaque	Visipaque	The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)

Primary Outcome Measures

Name	Time	Method
Creatinine Clearance	between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration	The variation of creatinine clearance before and after the product injection was measured

Trial Locations

Locations (1)

CHU Charles Nicolle; 🇫🇷 Rouen, France