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

Bayer

Status and phase: Completed; Phase 1

Conditions: Magnetic Resonance Imaging

Treatments: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468819

2006-004153-22 (EudraCT Number)

310788 (Other Identifier)

91552

Details and patient eligibility

About

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.

Full description

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

Enrollment: 140 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

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

Experimental group

Description:

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

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

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

Experimental group

Description:

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

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

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

Experimental group

Description:

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

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)