check_circleStudy Completed
Brain Diseases, Spinal Cord Diseases
Bayer Identifier:
91400
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Dose finding study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Trial purpose
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 with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
237Trial Dates
August 2005 - March 2007Phase
Phase 2Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Emory University School of Medicine | Atlanta, 30322, United States |
Completed | Hospital of the University of Pennsylvania | Philadelphia, 19104, United States |
Completed | NYU Langone Medical Center | New York, 10016, United States |
Completed | University of Washington Medical Center | Seattle, 98195, United States |
Terminated | Johns Hopkins University School of Medicine | Baltimore, 21287, United States |
Terminated | Northwestern Memorial Hospital | Chicago, 60611, United States |
Completed | Indiana Neuroscience Institute | Indianapolis, 46260, United States |
Completed | University of California Davis Medical Center | Sacramento, 95817, United States |
Terminated | Methodist Le Bonheur Healthcare | Memphis, 38104, United States |
Completed | TCba Salguero | Buenos Aires, Argentina |
Completed | Hospital da Beneficiência Portuguesa | Sao Paulo, 01323-001, Brazil |
Completed | DIME Clinica Neurocardiovascular S.A. | Cali, Colombia |
Terminated | Fundacion Cientifica del Sur | Lornas de Zamora, B1832BQS, Argentina |
Completed | Shands Jacksonville Medical Center | Jacksonville, 32209, United States |
Completed | CENTRO DE DIAGNOSTICO MEDICO | Medellín, Colombia |
Terminated | University of North Carolina | Chapel Hill, 27599, United States |
Completed | Washington University School of Medicine | St. Louis, 63110, United States |
Terminated | University of Wisconsin - Madison | Madison, 53792, United States |
Completed | University of Pittsburgh Medical Center Health System | Pittsburgh, 15213, United States |
Completed | Rhode Island Hospital | Providence, 02903, United States |
Terminated | Methodist Hospital | Omaha, 68114, United States |
Completed | Boston Medical Center | Boston, 02118, United States |
Completed | University of California-San Diego Medical Center | San Diego, 92103, United States |
Completed | Temple University Hospital | Philadelphia, 19146, United States |
Completed | Fundación Clínica Valle del Lili | Cali, Colombia |
Completed | Fundacion Cientifica del Sur | Lornas de Zamora, B1832BQS, Argentina |
Completed | Medical University of South Carolina | Charleston, 29425, United States |
Completed | Fundación Instituto de Alta tecnología médica de Antioquia | Medellín, Colombia |
Primary Outcome
- Categorical Visualization Score (CVS)date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Difference in number of lesions detected in pre-contrast and combined pre-/post-contrast MRIdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Assessment of Lesion Contrast Enhancement (difference)date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Assessment of border delineationdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Assessment of Internal morphologydate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Contrast to Noise ratio (CNR) between white and gray matter with Gadobutrol perfusion MRIdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Accuracy comparison of Gadobutrol doses – detection of matched lesions: blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Accuracy comparison of Gadobutrol doses – detection of matched lesions: blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Accuracy comparison of Gadobutrol doses – detection of matched lesions: blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Accuracy comparison of Gadobutrol doses – detection of matched enhanced lesions: blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Accuracy comparison of Gadobutrol doses – detection of matched enhanced lesions: blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Accuracy comparison of Gadobutrol doses – detection of matched enhanced lesions: blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of the correct diagnosis following gadobutrol-enhanced and unenhanced MRIdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of the diagnostic confidence based on unenhanced MRI and combined unenhanced and enhanced MRIdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (uncorrected cerebral blood volume (CBV)) – blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (uncorrected cerebral blood volume (CBV)) – blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (uncorrected cerebral blood volume (CBV)) – blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (corrected cerebral blood volume (CBV)) – blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (corrected cerebral blood volume (CBV)) – blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (corrected cerebral blood volume (CBV)) – blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (cerebral blood flow (CBF)) – blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (cerebral blood flow (CBF)) – blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (cerebral blood flow (CBF)) – blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (time to peak (TTP)) – blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (time to peak (TTP)) – blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (time to peak (TTP)) – blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (mean transit time (MTT)) – blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (mean transit time (MTT)) – blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (mean transit time (MTT)) – blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (Permeability factor (PF) – blinded reader 1date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (Permeability factor (PF) – blinded reader 2date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map quality (Permeability factor (PF)) – blinded reader 3date_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map parameter value (uncorrected cerebral blood volume (CBV)) – Independent Radiologistdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map parameter value (corrected cerebral blood volume (CBV)) – Independent Radiologistdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map parameter value (cerebral blood flow (CBF)) – Independent Radiologistdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map parameter value (time to peak (TTP)) – Independent Radiologistdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map parameter value (mean transit time (MTT)) – Independent Radiologistdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map parameter value (Permeability factor (PF)) – Independent Radiologistdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map artifacts (uncorrected cerebral blood volume (CBV)) – blinded readerdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map artifacts (corrected cerebral blood volume (CBV)) – blinded readerdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map artifacts (cerebral blood flow (CBF)) – blinded readerdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map artifacts (time to peak (TTP)) – blinded readerdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map artifacts (mean transit time (MTT)) – blinded readerdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of perfusion map artifacts (Permeability factor (PF)) – blinded readerdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Evaluation of MRI Tumor Grade agreement with biopsy Results by dose groupdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
- Contrast to Noise Ratio (CNR) of lesion/gray matter and lesion/white matterdate_rangeTime Frame:up to 2 hours after the injection of study medicationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3