Diagnostic Imaging Clinical Trial
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | CHU Charles Nicolle | Rouen |
Lead Sponsor | Collaborator |
---|---|
Guerbet |
France,
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 |
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