check_circleStudy Completed

Magnetic Resonance Imaging

Bayer Identifier:

91741

ClinicalTrials.gov Identifier:

NCT01544166

EudraCT Number:

2010-023003-96

EU CT Number:

Not Available
Gadobutrol pharmacokinetic and safety study in pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)

Trial purpose

The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol.
A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days.
Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate <80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial.
The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.

Key Participants Requirements

Sex

Both

Age

NaN - 2 Years
  • - Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)
    - Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region

  • - Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection
    - Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
    - Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
    - Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
    - Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
    - History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
    - Subject with renal insufficiency of any intensity, i.e. estimated Glomerular Filtration Rate <80% of age adjusted normal value calculated based on the Schwartz formula

Trial summary

Enrollment Goal
44
Trial Dates
May 2012 - November 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dresden, 01307, Germany
Completed
Halle, 06097, Germany
Completed
Jena, 07740, Germany
Completed
Edmonton, T6G 2B7, Canada
Withdrawn
New York, 10032, United States
Withdrawn
Atlanta, 30342-1605, United States
Completed
Houston, 77030, United States
Completed
Cincinnati, 45229, United States
Completed
Boston, 02111, United States
Completed
Chicago, 60611, United States
Completed
Savannah, 31406, United States

Primary Outcome

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual
    date_rangeTime Frame:
    Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual
    date_rangeTime Frame:
    Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual
    date_rangeTime Frame:
    Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual
    date_rangeTime Frame:
    Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual
    date_rangeTime Frame:
    Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)
    date_rangeTime Frame:
    20 minutes post-injection
    enhanced_encryption
    Safety Issue:
    No
  • Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)
    date_rangeTime Frame:
    30 minutes post-injection
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of Subjects With Anatomical Area Evaluated
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Technical Adequacy for Diagnosis
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Technical Adequacy for Diagnosis by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects by Overall Contrast Quality
    date_rangeTime Frame:
    Images were taken post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects by Overall Contrast Quality by Body Region
    date_rangeTime Frame:
    Images were taken post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects with Presence of Pathology by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Number of Lesions Detected
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Number of Lesions Detected by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Contrast Enhancement in Lesion or Vessel
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Contrast Enhancement in Lesion or Vessel by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Border Delineation of Lesion of Vessel
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Border Delineation of Lesion of Vessel by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects by Lesion Characterization or Homogeneity of Vessel Enhancement
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects by Lesion Characterization or Homogeneity of Vessel Enhancement by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Diagnoses
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Diagnoses by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects with Additional Diagnostic Gain
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects with Additional Diagnostic Gain by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects with Confidence in Diagnosis
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects with Confidence in Diagnosis by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Final Diagnosis
    date_rangeTime Frame:
    Up to 4 weeks post-injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Final Diagnosis by Body Region
    date_rangeTime Frame:
    Up to 4 weeks post-injection
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Management From Unenhanced to Combined MRI
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region
    date_rangeTime Frame:
    Images were taken pre-injection and post-injection (within about 15 minutes)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects With Clinically Significant Abnormal Laboratory Values
    date_rangeTime Frame:
    Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection
    date_rangeTime Frame:
    Before gadobutrol injection
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Open-label, multicenter, pharmacokinetic, and safety study in children (term newborn infants to 23 months of age) undergoing a contrast-enhanced MRI with an intravenous injection of 0.1 mmol/kg BW gadobutrol 1.0 M
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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