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

19. října 2015 aktualizováno: 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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Safety issues are addressed in the AE section

Typ studie

Intervenční

Zápis (Aktuální)

54

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

2 měsíce až 1 rok (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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)).
Lék: 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)).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Number of Lesions Detected - Stage 1
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Bayer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2010

Primární dokončení (Aktuální)

1. září 2010

Dokončení studie (Aktuální)

1. září 2010

Termíny zápisu do studia

První předloženo

10. července 2009

První předloženo, které splnilo kritéria kontroly kvality

10. července 2009

První zveřejněno (Odhad)

13. července 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

18. listopadu 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. října 2015

Naposledy ověřeno

1. října 2015

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 91784
  • 2009-013081-17 (Číslo EudraCT)
  • 312046 (Jiný identifikátor: company internal)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Magnetická rezonance

Klinické studie na Gadopentetate dimeglumine (Magnevist, BAY86-6661)

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Chile

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
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