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

19. oktober 2015 opdateret af: Bayer

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

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Safety issues are addressed in the AE section

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

54

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92123
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60614
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108-9898
      • St. Louis, Missouri, Forenede Stater, 63110
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
    • Texas
      • Houston, Texas, Forenede Stater, 77030
  • Tyskland
    • Sachsen
      • Dresden, Sachsen, Tyskland, 01307
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Tyskland, 06120
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Tyskland, 24105
    • Thüringen
      • Jena, Thüringen, Tyskland, 07740

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 måneder til 1 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)).
Medicin: 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)).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
Tidsramme: 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.
Within 5 minutes after injection
Dose Determined by Blinded Readers to be Superior for Diagnosis
Tidsramme: Within 5 minutes after injection
Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
Within 5 minutes after injection
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
Tidsramme: 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.
Within 5 minutes after injection
PK Analysis - Total Clearance (CL)
Tidsramme: 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.
20 to 45 min and 4 to 8 hours post injection
PK Analysis - Total Clearance (CL)/Body Weight (BW)
Tidsramme: 20 to 45 min and 4 to 8 hours post injection
CL/BW = total clearance normalized by BW
20 to 45 min and 4 to 8 hours post injection
PK Analysis - Volume of Distribution at Steady State (Vss)
Tidsramme: 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.
20 to 45 min and 4 to 8 hours post injection
PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
Tidsramme: 20 to 45 min and 4 to 8 hours post injection
Vss/BW = volume of distribution at steady state normalized by body weight
20 to 45 min and 4 to 8 hours post injection
PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
Tidsramme: 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
Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.
PK Analysis - t 1/2
Tidsramme: 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
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Number of Lesions Detected - Stage 1
Tidsramme: 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.
Within 5 minutes after injection
Number of Participants With Number of Lesions Detected - Stage 2
Tidsramme: 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.
Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 1
Tidsramme: 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)
Within 5 minutes after injection
Number of Participants With Quality of Lesion Visualization - Stage 2
Tidsramme: 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)
Within 5 minutes after injection
Number of Participants With Quality of Border Delineation - Stage 1
Tidsramme: 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
Within 5 minutes after injection
Number of Participants With Quality of Border Delineation - Stage 2
Tidsramme: 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
Within 5 minutes after injection
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
Tidsramme: 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
Within 5 minutes after injection
Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
Tidsramme: 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
Within 5 minutes after injection
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
Tidsramme: 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
Within 5 minutes after injection
Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
Tidsramme: 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
Within 5 minutes after injection
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
Tidsramme: 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.
Within 5 minutes after injection
Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
Tidsramme: 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
Within 5 minutes after injection
Number of Participants With Diagnostic Confidence - Stage 1
Tidsramme: 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
Within 5 minutes after injection
Number of Participants With Diagnostic Confidence - Stage 2
Tidsramme: 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
Within 5 minutes after injection
Management Based on Unenhanced Images - Stage 1
Tidsramme: 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.
Within 5 minutes before injection
Management Based on Unenhanced Images - Stage 2
Tidsramme: 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.
Within 5 minutes before injection
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1
Tidsramme: 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.
Within 5 minutes after injection
Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2
Tidsramme: 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.
Within 5 minutes after injection
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
Tidsramme: 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
Within 5 minutes after injection
Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
Tidsramme: 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
Within 5 minutes after injection

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. september 2010

Studieafslutning (Faktiske)

1. september 2010

Datoer for studieregistrering

Først indsendt

10. juli 2009

Først indsendt, der opfyldte QC-kriterier

10. juli 2009

Først opslået (Skøn)

13. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 91784
  • 2009-013081-17 (EudraCT nummer)
  • 312046 (Anden identifikator: company internal)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med MR scanning

Kliniske forsøg med Gadopentetate dimeglumine (Magnevist, BAY86-6661)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

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Betingelser

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