Trial Condition(s):
Central nervous system diseases
Safety and efficacy of gadobutrol 1.0 molar ( Gadavist ) in patients for central nervous system (CNS) imaging
Bayer Identifier:
91682
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Cedars- Sinai Medical Center Los Angeles, United States, 90048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Sinai Medical Center New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Henry Ford Health System Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Rochester Medical Center Rochester, United States, 14642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sharp & Children's MRI Center San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landmark Imaging Medical Group Los Angeles, United States, 90025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of South Florida Tampa, United States, 33606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bio-Magnetic Resonance, Inc. Madison Heights, United States, 48071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hahnemann University Hospital Philadelphia, United States, 19102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eisenhower Army Medical Center Fort Gordon, United States, 30905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical University of South Carolina Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allegheny General Hospital Pittsburgh, United States, 15212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HOPE Research Institute, LLC Phoenix, United States, 85050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigaciones Médicas Buenos Aires, Argentina, C1082A | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida - Jacksonville Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baylor College of Medicine Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiology Ltd. Tucson, United States, 85711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wake Forest University School of Medicine Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scottsdale Medical Imaging, Ltd. Scottsdale, United States, 85258 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Health System Ann Arbor, United States, 48109-5302 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations River Birch Research Alliance, LLC Blue Ridge, United States, 30513 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maimonides Medical Center Brooklyn, United States, 11219 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eisenhower Army Medical Center Fort Gordon, United States, 30905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Italiano Buenos Aires Buenos Aires, Argentina, C1181ACH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Diagnóstico Dr. Enrique Rossi Buenos Aires, Argentina, C1425BEE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Santa Fe de Bogotá - Hospital Universitario Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chinese PLA General Hosp. Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The 1st Affiliated Hosp of the 4th Military Med Uni Xi'an, China, 710032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Milbet Diagnostico por Imagenes Buenos Aires, Argentina, C1115AAB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Instituto de Alta tecnología médica de Antioquia Medellín, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fudan University Huashan Hospital Shanghai, China, 200040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School Shanghai, China, 200025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-799 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Severance Hospital, Yonsei University College of Medicine Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Catholic University of Korea Seoul St. Mary's Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhongda Hosp. affiliated of Southeast Univ. Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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)Timeframe: Up to 2 hours after injection of gadobutrol
- 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
- 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
- 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
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded ReadersTimeframe: Up to 2 hours after injection of gadobutrol
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 InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)Timeframe: Up to 2 hours after injection of gadobutrol
- Scores for Contrast Enhancement for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- 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 InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority ReaderTimeframe: Up to 2 hours after injection of gadobutrol
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical InvestigatorTimeframe: Up to 2 hours after injection of gadobutrol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol
- 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) ImagesTimeframe: Up to 2 hours after injection of gadobutrol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerTimeframe: Up to 2 hours after injection of gadobutrol
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by average readerTimeframe: Up to 2 hours after injection of gadobutrol
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatorTimeframe: Up to 2 hours after injection of gadobutrol
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