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

April 8, 2013 updated by: Guerbet
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • CHU Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Investigators

  • Study Chair: Corinne Dubourdieu, PhD, Guerbet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISO-44-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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