Diagnostic ImagingPhase 4NCT00347022
A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
A Phase 4 study testing Xenetix and Visipaque in people with Diagnostic Imaging, run by Guerbet at 1 site in France.
Trial summary
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- Xenetix and Visipaque
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
- Conditions
- Diagnostic Imaging
- Being tested
- Xenetix, Visipaque
- Keywords
- Multislice computed tomography (MSCT)indications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenetixDrug
300 mg of iodine/ml
VisipaqueDrug
270 mg of iodine/ml
| Study group | Role | What they receive |
|---|---|---|
| Xenetix | Experimental | The patient receive one injection of Xenetix 300 (300 mg of iodine/ml) Receives: Drug: Xenetix |
| Visipaque | Active comparator | The patient receive one injection of Visipaque 270 (270 mg of iodine/ml) Receives: Drug: Visipaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine Clearance
The variation of creatinine clearance before and after the product injection was measured
Measured: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corinne Dubourdieu, PhD, Study chair, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347022
- Sponsor's protocol ID
- ISO-44-008
- Status last verified
- Apr 2013
- First submitted
- 30 Jun 2006
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
- ClinicalTrials.gov ID
- NCT00347022
- Acronym / sponsor ID
- ISO-44-008
- Conditions
- Diagnostic Imaging
- Keywords
- Multislice computed tomography (MSCT)indications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenetix | Experimental | Drug: XenetixThe patient receive one injection of Xenetix 300 (300 mg of iodine/ml) |
| Visipaque | Active comparator | Drug: VisipaqueThe patient receive one injection of Visipaque 270 (270 mg of iodine/ml) |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenetix300 mg of iodine/ml | Drug | Xenetix |
| Visipaque270 mg of iodine/ml | Drug | Visipaque |
Primary outcome
Creatinine Clearance
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diagnostic Imaging
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Vulvar Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Dubourdieu, PhD study chair
Guerbet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xenetix and Visipaque in people with Diagnostic Imaging, run by Guerbet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine Clearance (time frame: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.