Clinical trial NCT00623467: Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Nervous System Diseases
Keywords: Central Nervous System Imaging
Diagnostic Imaging
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Issues on safety will be addressed in Adverse Events section.

Eligibility criteria: Inclusion Criteria:

* Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.

Exclusion Criteria:

* Patients with acute renal insufficiency
* Patients with severe renal disease
* Patients with any contraindication to magnetic resonance imaging.

Primary outcomes:
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)
timeFrame: Up to 2 hours after injection of gadobutrol
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 2 (BR2)
timeFrame: Up to 2 hours after injection of gadobutrol
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 3 (BR3)
timeFrame: Up to 2 hours after injection of gadobutrol
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 Average Reader (AR)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
timeFrame: Up to 2 hours after injection of gadobutrol
Secondary outcomes:
measure: 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
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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 Reader (AR)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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
timeFrame: Up to 2 hours after injection of gadobutrol
measure: 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
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Ltd.
state: Arizona
city: Tucson
country: United States
facility: Radiology Ltd.
state: Arizona
city: Los Angeles
country: United States
facility: Landmark Imaging Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars- Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Sharp & Children's MRI Center
state: California
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Fort Gordon
country: United States
facility: Eisenhower Army Medical Center
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Madison Heights
country: United States
facility: Bio-Magnetic Resonance, Inc.
state: Michigan
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Buenos Aires
country: Argentina
facility: Investigaciones Médicas
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Milbet Diagnostico por Imagenes
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano Buenos Aires
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Diagnóstico Dr. Enrique Rossi
state: Ciudad Auton. de Buenos Aires
city: Nanjing
country: China
facility: Zhongda Hosp. affiliated of Southeast Univ.
state: Jiangsu
city: Xi'an
country: China
facility: The 1st Affiliated Hosp of the 4th Military Med Uni
state: Shaanxi
city: Beijing
country: China
facility: Chinese PLA General Hosp.
city: Shanghai
country: China
facility: Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School
city: Shanghai
country: China
facility: Fudan University Huashan Hospital
city: Medellín
country: Colombia
facility: Fundación Instituto de Alta tecnología médica de Antioquia
state: Antioquia
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá - Hospital Universitario
state: Cundinamarca
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: