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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet

Criteria

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