A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children

NCT ID: NCT00468819

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-04-30

Brief Summary

In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.

Detailed Description

Please note that the present study is allocated two study phases, i.e. phase I and phase III.

Conditions

Magnetic Resonance Imaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gadobutrol (Gadavist, BAY86-4875) - age 2 to 6 years

Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection

Group Type: EXPERIMENTAL

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection

Gadobutrol (Gadavist, BAY86-4875) - age 7 to 11 years

Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection

Group Type: EXPERIMENTAL

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection

Gadobutrol (Gadavist, BAY86-4875) - age 12 to 17 years

Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection

Group Type: EXPERIMENTAL

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection

Gadobutrol (Gadavist, BAY86-4875) - age 2 to 17 years

Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection

Group Type: EXPERIMENTAL

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection

Interventions

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years) who are scheduled to undergo Gadolinium (Gd)-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view).

Exclusion Criteria

• Clinically unstable patients (e.g. intensive care unit)
• Renal insufficiency
• Patients undergoing a relevant change in chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Gadovist.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Vienna, Vienna, Austria

Edmonton, Alberta, Canada

Toronto, Ontario, Canada

Erlangen, Bavaria, Germany

Bonn, North Rhine-Westphalia, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Halle, Saxony-Anhalt, Germany

Kiel, Schleswig-Holstein, Germany

Kiel, Schleswig-Holstein, Germany

Jena, Thuringia, Germany

Gothenburg, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Countries

Austria; Canada; Germany; Sweden

References

Hahn G, Sorge I, Gruhn B, Glutig K, Hirsch W, Bhargava R, Furtner J, Born M, Schroder C, Ahlstrom H, Kaiser S, Moritz JD, Kunze CW, Shroff M, Stokland E, Trnkova ZJ, Schultze-Mosgau M, Reif S, Bacher-Stier C, Mentzel HJ. Pharmacokinetics and safety of gadobutrol-enhanced magnetic resonance imaging in pediatric patients. Invest Radiol. 2009 Dec;44(12):776-83. doi: 10.1097/RLI.0b013e3181bfe2d2.

Reference Type: RESULT

PMID: 19858730 (View on PubMed)

Reif S, Schultze-Mosgau M, Sutter G. From adults to children: simulation-based choice of an appropriate sparse-sampling schedule. Paediatr Drugs. 2012 Jun 1;14(3):189-200. doi: 10.2165/11595430-000000000-00000.

Reference Type: RESULT

PMID: 22409261 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2006-004153-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

310788

Identifier Type: OTHER

Identifier Source: secondary_id

91552

Identifier Type: -

Identifier Source: org_study_id