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Completed

NCT Number: NCT00937391

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

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

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Key information

Conditions

Magnetic Resonance Imaging

Age range

2 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dresden, Saxony, Germany

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About this study

Safety issues are addressed in the AE section

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gadopentetate dimeglumine (Magnevist, BAY86-6661)

Drug

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)).

Primary outcomes

  1. Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)

    Time frame: Within 5 minutes after injection

    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.

  2. Dose Determined by Blinded Readers to be Superior for Diagnosis

    Time frame: Within 5 minutes after injection

    Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters

  3. 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

    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.

  4. PK Analysis - Total Clearance (CL)

    Time frame: 20 to 45 min and 4 to 8 hours post injection

    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.

  5. PK Analysis - Total Clearance (CL)/Body Weight (BW)

    Time frame: 20 to 45 min and 4 to 8 hours post injection

    CL/BW = total clearance normalized by BW

  6. PK Analysis - Volume of Distribution at Steady State (Vss)

    Time frame: 20 to 45 min and 4 to 8 hours post injection

    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.

  7. 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

    Vss/BW = volume of distribution at steady state normalized by body weight

  8. 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.

    AUC = Area under the drug concentration-time curve from administration to infinity

  9. 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

    t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity

Secondary outcomes

  1. Number of Participants With Number of Lesions Detected - Stage 1

    Time frame: Within 5 minutes after injection

    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.

  2. Number of Participants With Number of Lesions Detected - Stage 2

    Time frame: Within 5 minutes after injection

    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.

  3. Number of Participants With Quality of Lesion Visualization - Stage 1

    Time frame: Within 5 minutes after injection

    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)

  4. Number of Participants With Quality of Lesion Visualization - Stage 2

    Time frame: Within 5 minutes after injection

    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)

  5. Number of Participants With Quality of Border Delineation - Stage 1

    Time frame: Within 5 minutes after injection

    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

  6. Number of Participants With Quality of Border Delineation - Stage 2

    Time frame: Within 5 minutes after injection

    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

  7. Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1

    Time frame: Within 5 minutes after injection

    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

  8. Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2

    Time frame: Within 5 minutes after injection

    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

  9. Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1

    Time frame: Within 5 minutes after injection

    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

  10. Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2

    Time frame: Within 5 minutes after injection

    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

  11. Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1

    Time frame: Within 5 minutes after injection

    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.

  12. Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2

    Time frame: Within 5 minutes after injection

    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

  13. Number of Participants With Diagnostic Confidence - Stage 1

    Time frame: Within 5 minutes after injection

    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

  14. Number of Participants With Diagnostic Confidence - Stage 2

    Time frame: Within 5 minutes after injection

    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

  15. Management Based on Unenhanced Images - Stage 1

    Time frame: Within 5 minutes before injection

    For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.

  16. Management Based on Unenhanced Images - Stage 2

    Time frame: Within 5 minutes before injection

    For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.

  17. Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1

    Time frame: Within 5 minutes after injection

    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.

  18. Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2

    Time frame: Within 5 minutes after injection

    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.

  19. Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1

    Time frame: Within 5 minutes after injection

    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

  20. Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2

    Time frame: Within 5 minutes after injection

    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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2009
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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