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

Diagnostic Imaging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347022
• Other study ID #: ISO-44-008
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2006
• Last updated: April 8, 2013
• Start date: May 2006
• Est. completion date: June 2009

Study information

• Verified date: April 2013
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Drug:
• Xenetix
300 mg of iodine/ml
• Visipaque
270 mg of iodine/ml

Locations

Country	Name	City	State
France	CHU Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine Clearance	The variation of creatinine clearance before and after the product injection was measured	between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration	Yes