check_circleStudy Completed

Central Nervous System Diseases

Bayer Identifier:

91682

ClinicalTrials.gov Identifier:

NCT00623467

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and efficacy of gadobutrol 1.0 molar ( Gadavist ) in patients for central nervous system (CNS) imaging

Trial purpose

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.
  • - Patients with acute renal insufficiency
    - Patients with severe renal disease
    - Patients with any contraindication to magnetic resonance imaging.

Trial summary

Enrollment Goal
343
Trial Dates
December 2007 - December 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Cedars- Sinai Medical CenterLos Angeles, 90048, United States
Terminated
Mount Sinai Medical CenterNew York, 10029, United States
Completed
Henry Ford Health SystemDetroit, 48202, United States
Terminated
University of Rochester Medical CenterRochester, 14642, United States
Terminated
Sharp & Children's MRI CenterSan Diego, 92123, United States
Terminated
Landmark Imaging Medical GroupLos Angeles, 90025, United States
Terminated
University of South FloridaTampa, 33606, United States
Terminated
Bio-Magnetic Resonance, Inc.Madison Heights, 48071, United States
Completed
Hahnemann University HospitalPhiladelphia, 19102, United States
Completed
Eisenhower Army Medical CenterFort Gordon, 30905, United States
Terminated
Medical University of South CarolinaCharleston, 29425, United States
Completed
Allegheny General HospitalPittsburgh, 15212, United States
Terminated
HOPE Research Institute, LLCPhoenix, 85050, United States
Completed
Investigaciones MédicasBuenos Aires, C1082A, Argentina
Completed
University of Florida - JacksonvilleJacksonville, 32209, United States
Terminated
Baylor College of MedicineHouston, 77030, United States
Completed
Radiology Ltd.Tucson, 85711, United States
Terminated
Wake Forest University School of MedicineWinston-Salem, 27157, United States
Completed
Scottsdale Medical Imaging, Ltd.Scottsdale, 85258, United States
Terminated
University of Michigan Health SystemAnn Arbor, 48109-5302, United States
Terminated
River Birch Research Alliance, LLCBlue Ridge, 30513, United States
Terminated
Maimonides Medical CenterBrooklyn, 11219, United States
Terminated
Eisenhower Army Medical CenterFort Gordon, 30905, United States
Completed
Hospital Italiano Buenos AiresBuenos Aires, C1181ACH, Argentina
Completed
Centro de Diagnóstico Dr. Enrique RossiBuenos Aires, C1425BEE, Argentina
Completed
Fundación Santa Fe de Bogotá - Hospital UniversitarioBogotá, Colombia
Completed
Chinese PLA General Hosp.Beijing, 100853, China
Completed
The 1st Affiliated Hosp of the 4th Military Med UniXi'an, 710032, China
Completed
Milbet Diagnostico por ImagenesBuenos Aires, C1115AAB, Argentina
Completed
Fundación Instituto de Alta tecnología médica de AntioquiaMedellín, Colombia
Terminated
Fudan University Huashan HospitalShanghai, 200040, China
Completed
Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med SchoolShanghai, 200025, China
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-799, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, 120-752, Korea, Republic Of
Completed
The Catholic University of Korea Seoul St. Mary's HospitalSeoul, 110-744, Korea, Republic Of
Completed
Zhongda Hosp. affiliated of Southeast Univ.Nanjing, 210009, China

Primary Outcome

  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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 2 (BR2)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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 3 (BR3)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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 Average Reader (AR)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Readers
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Scores for Three Visualization Parameters (Contrast enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Reader 1 (BR1)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Reader 2 (BR2)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Reader 3 (BR3)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Average Reader (AR)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for normal structures for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Reader 1 (BR1)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for normal structures for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Reader 2 (BR2)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for normal structures for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Reader 3 (BR3)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for normal structures for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Average Rreader (AR)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Contrast Enhancement for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for normal structures for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority Reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by average reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No

Trial design

A multicenter, open-label, 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).
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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