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A Multicenter, Randomized, Double-blind, Crossover, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)


Phase 3
18 Years
N/A
Not Enrolling
Both
Diagnostic Imaging, Central Nervous System Diseases

Thank you

Trial Information

A Multicenter, Randomized, Double-blind, Crossover, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)


Issues on safety will be addressed in Adverse Events section.


Inclusion Criteria:



- Is at least 18 years of age

- Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms
or results of a previous imaging procedure

- Has been fully informed about the study, including provisions of the Health Insurance
Portability and Accountability Act (HIPAA) as applicable, and has consented to
participate

Exclusion Criteria:

- Has any contraindication to the MRI examinations or the use of Gd-containing contrast
agents

- Has a history of severe allergic or anaphylactoid reaction to any allergen including
drugs and contrast agents

- Has severe cardiovascular disease (eg, known long QT syndrome, acute myocardial
infarction [< 14 days], unstable angina, congestive heart failure New York Heart
Association class IV) or acute stroke (< 48 hours)- Patients with acute renal
insufficiency of any severity due to hepato-renal syndrome or in the perioperative
liver transplantation period

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)

Outcome Description:

BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.

Outcome Time Frame:

Up to 2 hours after injection of gadobutrol

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

91681

NCT ID:

NCT00709852

Start Date:

June 2008

Completion Date:

April 2009

Related Keywords:

  • Diagnostic Imaging
  • Central Nervous System Diseases
  • Patients referred for a contrast-enhanced MRI of the CNS
  • CNS Imaging
  • Central Nervous System Diseases
  • Nervous System Diseases

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington Medical CenterSeattle, Washington  98195-6043
Rhode Island HospitalProvidence, Rhode Island  02903
Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
Duke University Medical CenterDurham, North Carolina  27710
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of Maryland Hospital SystemBaltimore, Maryland  21201-1595
The Cleveland ClinicCleveland, Ohio  44195
Redwood Regional Medical Group, Inc.Santa Rosa, California  95403
Aurora Saint Luke's Medical CenterMilwaukee, Wisconsin  53215
University of Florida - JacksonvilleJacksonville, Florida  32209
West Alabama Research, Inc.Birmingham, Alabama  35209
Achieve Clinical Research, LLCTuscaloosa, Alabama  35406
Los Gatos MRILos Gatos, California  95032
NorthShore University HealthSystem-Evanston HospitalEvanston, Illinois  60201
Atchison HospitalAtchison, Kansas  66002
Johns Hopkins Hospital/Health SystemBaltimore, Maryland  21287
Shields MRI - BrocktonBrockton, Massachusetts  02301
VA Boston Healthcare System-West Roxbury DivisionWest Roxbury, Massachusetts  02132
Kingston Neurological Associates, PCKingston, New York  12401
NYU Hospital for Joint DiseasesNew York, New York  10003