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

Guerbet

Status and phase

Completed

Phase 4

Conditions

Diagnostic Imaging

Treatments

Drug: Visipaque

Drug: Xenetix

Study type

Interventional

Funder types

Industry

Identifiers

ISO-44-008

Details and patient eligibility

About

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

Enrollment

145 patients

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

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