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

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

Conditions
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Diagnostic Imaging

Intervention / Treatment
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* Drug: Xenetix
* Drug: Visipaque


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xenetix<br>The patient receive one injection of Xenetix 300 (300 mg of iodine/ml) | Drug: Xenetix<br>* 300 mg of iodine/ml<br>|
| Active Comparator: Visipaque<br>The patient receive one injection of Visipaque 270 (270 mg of iodine/ml) | Drug: Visipaque<br>* 270 mg of iodine/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multislice computed tomography (MSCT)indications