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

Magnetic Resonance Imaging Clinical Trial

Official title:

Open-label, Multi-center, Two-stage, Age Stratified, Pharmacokinetic, Safety, and Efficacy Study in Children 2 Months to < 2 Years of Age Undergoing Magnevist Injection Enhanced MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937391
• Other study ID #: 91784
• Secondary ID: 2009-013081-1731
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2009
• Last updated: October 19, 2015
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Description:

Safety issues are addressed in the AE section

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 23 Months

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Drug:
• Gadopentetate dimeglumine (Magnevist, BAY86-6661)
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)).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)	A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.	Within 5 minutes after injection	No
Primary	Dose Determined by Blinded Readers to be Superior for Diagnosis	Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters	Within 5 minutes after injection	No
Primary	Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers	For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.	Within 5 minutes after injection	No
Primary	PK Analysis - Total Clearance (CL)	Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.	20 to 45 min and 4 to 8 hours post injection	No
Primary	PK Analysis - Total Clearance (CL)/Body Weight (BW)	CL/BW = total clearance normalized by BW	20 to 45 min and 4 to 8 hours post injection	No
Primary	PK Analysis - Volume of Distribution at Steady State (Vss)	Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.	20 to 45 min and 4 to 8 hours post injection	No
Primary	PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)	Vss/BW = volume of distribution at steady state normalized by body weight	20 to 45 min and 4 to 8 hours post injection	No
Primary	PK Analysis - Area Under the Drug Concentration-time Curve (AUC)	AUC = Area under the drug concentration-time curve from administration to infinity	Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.	No
Primary	PK Analysis - t 1/2	t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity	Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity	No
Secondary	Number of Participants With Number of Lesions Detected - Stage 1	BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.	Within 5 minutes after injection	No
Secondary	Number of Participants With Number of Lesions Detected - Stage 2	BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.	Within 5 minutes after injection	No
Secondary	Number of Participants With Quality of Lesion Visualization - Stage 1	BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)	Within 5 minutes after injection	No
Secondary	Number of Participants With Quality of Lesion Visualization - Stage 2	BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)	Within 5 minutes after injection	No
Secondary	Number of Participants With Quality of Border Delineation - Stage 1	BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set	Within 5 minutes after injection	No
Secondary	Number of Participants With Quality of Border Delineation - Stage 2	BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set	Within 5 minutes after injection	No
Secondary	Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1	BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images	Within 5 minutes after injection	No
Secondary	Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2	BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images	Within 5 minutes after injection	No
Secondary	Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1	The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator	Within 5 minutes after injection	No
Secondary	Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2	The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator	Within 5 minutes after injection	No
Secondary	Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1	Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator.	Within 5 minutes after injection	No
Secondary	Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2	Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator	Within 5 minutes after injection	No
Secondary	Number of Participants With Diagnostic Confidence - Stage 1	The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator	Within 5 minutes after injection	No
Secondary	Number of Participants With Diagnostic Confidence - Stage 2	The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator	Within 5 minutes after injection	No
Secondary	Management Based on Unenhanced Images - Stage 1	For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.	Within 5 minutes before injection	No
Secondary	Management Based on Unenhanced Images - Stage 2	For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.	Within 5 minutes before injection	No
Secondary	Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1	For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.	Within 5 minutes after injection	No
Secondary	Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2	For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.	Within 5 minutes after injection	No
Secondary	Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1	The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1	Within 5 minutes after injection	No
Secondary	Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2	The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1	Within 5 minutes after injection	No

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