Contrast-enhanced MRI in Children 2 Months to <2 Years
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00937391
First received: July 10, 2009
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
| Condition | Intervention | Phase |
|---|---|---|
|
Magnetic Resonance Imaging |
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-6661) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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.
- Dose Determined by Blinded Readers to be Superior for Diagnosis [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
- Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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.
- PK Analysis - Total Clearance (CL) [ Time Frame: 20 to 45 min and 4 to 8 hours post injection ] [ Designated as safety issue: No ]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.
- PK Analysis - Total Clearance (CL)/Body Weight (BW) [ Time Frame: 20 to 45 min and 4 to 8 hours post injection ] [ Designated as safety issue: No ]CL/BW = total clearance normalized by BW
- PK Analysis - Volume of Distribution at Steady State (Vss) [ Time Frame: 20 to 45 min and 4 to 8 hours post injection ] [ Designated as safety issue: No ]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.
- PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW) [ Time Frame: 20 to 45 min and 4 to 8 hours post injection ] [ Designated as safety issue: No ]Vss/BW = volume of distribution at steady state normalized by body weight
- PK Analysis - Area Under the Drug Concentration-time Curve (AUC) [ Time Frame: Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity. ] [ Designated as safety issue: No ]AUC = Area under the drug concentration-time curve from administration to infinity
- PK Analysis - t 1/2 [ Time Frame: 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 ] [ Designated as safety issue: No ]t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
Secondary Outcome Measures:
- Number of Participants With Number of Lesions Detected - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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.
- Number of Participants With Number of Lesions Detected - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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.
- Number of Participants With Quality of Lesion Visualization - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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)
- Number of Participants With Quality of Lesion Visualization - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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)
- Number of Participants With Quality of Border Delineation - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Number of Participants With Quality of Border Delineation - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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.
- Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Number of Participants With Diagnostic Confidence - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Number of Participants With Diagnostic Confidence - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Management Based on Unenhanced Images - Stage 1 [ Time Frame: Within 5 minutes before injection ] [ Designated as safety issue: No ]For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
- Management Based on Unenhanced Images - Stage 2 [ Time Frame: Within 5 minutes before injection ] [ Designated as safety issue: No ]For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
- Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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.
- Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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.
- Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
- Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 [ Time Frame: Within 5 minutes after injection ] [ Designated as safety issue: No ]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
| Enrollment: | 54 |
| Study Start Date: | January 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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)).
|
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)).
|
Detailed Description:
Safety issues are addressed in the AE section
Eligibility| Ages Eligible for Study: | 2 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937391
Locations
| United States, California | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60614 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Missouri | |
| Kansas City, Missouri, United States, 64108-9898 | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44308 | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Germany | |
| Halle, Sachsen-Anhalt, Germany, 06120 | |
| Dresden, Sachsen, Germany, 01307 | |
| Kiel, Schleswig-Holstein, Germany, 24105 | |
| Jena, Thüringen, Germany, 07740 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00937391 History of Changes |
| Other Study ID Numbers: | 91784, 2009-014584-39, 312046 |
| Study First Received: | July 10, 2009 |
| Results First Received: | September 8, 2011 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bayer:
|
MRI agents Magnevist |
ClinicalTrials.gov processed this record on May 23, 2013