Diagnostic Imaging
Conditions
Keywords
Multislice computed tomography (MSCT)indications
Brief summary
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
Interventions
DRUGXenetix
300 mg of iodine/ml
DRUGVisipaque
270 mg of iodine/ml
Sponsors
Guerbet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine Clearance | between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration | The variation of creatinine clearance before and after the product injection was measured |
Countries
France
Participant flow
Recruitment details
First patient first visit = 30/05/2006 Last patient last visit = 14/04/2009 Location = radiological department (Hospitals)
Pre-assignment details
Any patient having a creatinine clearance \< 60ml/min/1.73m² at time of baseline blood sample and/or positive beta HCG (Human Chorionic Gonadotropin) within 48h before contrast medium administration was considered as immediate withdrawal from trial
Participants by arm
| Arm | Count |
|---|---|
| Xenetix Patient will be injected with Xenetix 300 | 74 |
| Visipaque Patient will be injected with Visipaque 270 | 71 |
| Total | 145 |
Baseline characteristics
| Characteristic | Xenetix | Visipaque | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 74 Participants | 71 Participants | 145 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 8.7 years STANDARD_DEVIATION 4.8 | 8.1 years STANDARD_DEVIATION 4.7 | 8.4 years STANDARD_DEVIATION 4.7 |
| Region of Enrollment Austria | 15 participants | 15 participants | 30 participants |
| Region of Enrollment France | 59 participants | 56 participants | 115 participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 59 Participants |
| Sex: Female, Male Male | 43 Participants | 43 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 74 | 13 / 71 |
| serious Total, serious adverse events | 5 / 74 | 4 / 71 |
Outcome results
Primary
Creatinine Clearance
The variation of creatinine clearance before and after the product injection was measured
Time frame: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xenetix | Creatinine Clearance | 1.1 percent change | Standard Deviation 19.7 |
| Visipaque | Creatinine Clearance | 1.9 percent change | Standard Deviation 22 |