Contrast-enhanced MRI in Children 2 Months to <2 Years

Bayer

Status and phase: Completed; Phase 3

Conditions: Magnetic Resonance Imaging

Treatments: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-6661)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937391

91784

312046 (Other Identifier)

2009-013081-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age

Full description

Safety issues are addressed in the AE section

Enrollment: 54 patients

Sex: All

Ages: 2 to 23 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 2 months to < 2 years (23 months)
• Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
• Able to comply with the study procedures

Exclusion criteria

• Clinical unstable participants (eg, intensive care unit)
• Renal Insufficiency
• Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Magnevist.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Gadopentetate dimeglumine (Magnevist, BAY86-6661)

Experimental group

Description:

For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-6661)