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

maanantai 19. lokakuuta 2015 päivittänyt: 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

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Safety issues are addressed in the AE section

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

54

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

2 kuukautta - 1 vuosi (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Diagnostiikka
  • Jako: Ei satunnaistettu
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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)).
Lääke: 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)).

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Number of Lesions Detected - Stage 1
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Bayer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Perjantai 1. tammikuuta 2010

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 1. syyskuuta 2010

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. syyskuuta 2010

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 10. heinäkuuta 2009

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 10. heinäkuuta 2009

Ensimmäinen Lähetetty (Arvio)

Maanantai 13. heinäkuuta 2009

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Keskiviikko 18. marraskuuta 2015

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 19. lokakuuta 2015

Viimeksi vahvistettu

Torstai 1. lokakuuta 2015

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muut tutkimustunnusnumerot

  • 91784
  • 2009-013081-17 (EudraCT-numero)
  • 312046 (Muu tunniste: company internal)

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

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