check_circleStudy Completed
Central Nervous System Diseases
Bayer Identifier:infoA unique number for a trial given by Bayer.
91682
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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
BothAge
18 YearsTrial summary
Enrollment Goal info
343The overall number of participants needed for a trial.
Trial Dates info
December 2007 - December 2008Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Gadavist/Gadovist (Gadobutrol, BAY86-4875)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Terminated | Cedars- Sinai Medical Center | Los Angeles, 90048, United States |
Terminated | Mount Sinai Medical Center | New York, 10029, United States |
Completed | Henry Ford Health System | Detroit, 48202, United States |
Terminated | University of Rochester Medical Center | Rochester, 14642, United States |
Terminated | Sharp & Children's MRI Center | San Diego, 92123, United States |
Terminated | Landmark Imaging Medical Group | Los Angeles, 90025, United States |
Terminated | University of South Florida | Tampa, 33606, United States |
Terminated | Bio-Magnetic Resonance, Inc. | Madison Heights, 48071, United States |
Completed | Hahnemann University Hospital | Philadelphia, 19102, United States |
Completed | Eisenhower Army Medical Center | Fort Gordon, 30905, United States |
Terminated | Medical University of South Carolina | Charleston, 29425, United States |
Completed | Allegheny General Hospital | Pittsburgh, 15212, United States |
Terminated | HOPE Research Institute, LLC | Phoenix, 85050, United States |
Completed | Investigaciones Médicas | Buenos Aires, C1082A, Argentina |
Completed | University of Florida - Jacksonville | Jacksonville, 32209, United States |
Terminated | Baylor College of Medicine | Houston, 77030, United States |
Completed | Radiology Ltd. | Tucson, 85711, United States |
Terminated | Wake Forest University School of Medicine | Winston-Salem, 27157, United States |
Completed | Scottsdale Medical Imaging, Ltd. | Scottsdale, 85258, United States |
Terminated | University of Michigan Health System | Ann Arbor, 48109-5302, United States |
Terminated | River Birch Research Alliance, LLC | Blue Ridge, 30513, United States |
Terminated | Maimonides Medical Center | Brooklyn, 11219, United States |
Terminated | Eisenhower Army Medical Center | Fort Gordon, 30905, United States |
Completed | Hospital Italiano Buenos Aires | Buenos Aires, C1181ACH, Argentina |
Completed | Centro de Diagnóstico Dr. Enrique Rossi | Buenos Aires, C1425BEE, Argentina |
Completed | Fundación Santa Fe de Bogotá - Hospital Universitario | Bogotá, Colombia |
Completed | Chinese PLA General Hosp. | Beijing, 100853, China |
Completed | The 1st Affiliated Hosp of the 4th Military Med Uni | Xi'an, 710032, China |
Completed | Milbet Diagnostico por Imagenes | Buenos Aires, C1115AAB, Argentina |
Completed | Fundación Instituto de Alta tecnología médica de Antioquia | Medellín, Colombia |
Terminated | Fudan University Huashan Hospital | Shanghai, 200040, China |
Completed | Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School | Shanghai, 200025, China |
Completed | Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Seoul National University Hospital | Seoul, 110-799, Korea, Republic Of |
Completed | Samsung Medical Center | Seoul, 135-710, Korea, Republic Of |
Completed | Severance Hospital, Yonsei University College of Medicine | Seoul, 120-752, Korea, Republic Of |
Completed | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul, 110-744, Korea, Republic Of |
Completed | Zhongda Hosp. affiliated of Southeast Univ. | Nanjing, 210009, China |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Readersdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome 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 Investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- 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 gadobutrolenhanced_encryptionNoSafety Issue:
- Scores for Contrast Enhancement for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- 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 Investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority Readerdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- 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) Imagesdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- 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) Imagesdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- 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) Imagesdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority readerdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by average readerdate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
- Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigatordate_rangeTime Frame:Up to 2 hours after injection of gadobutrolenhanced_encryptionNoSafety Issue:
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
DiagnosticThe main reason the clinical trial is being done.
Allocation info
Non-randomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Open Label“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Single Group AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
1A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.