Trial Condition(s):
Магнито-резонансная томография
Comparison of Gadovist 75% standard dose to Dotarem at full standard dose (LEADER 75)
Bayer Identifier:
19773
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Цель исследования
The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). МРТ — способ получения изображений анатомии тела, использующийся для обнаружения патологии организма. Такие диагностические препараты, как гадобутрол и гадотерат содержат элемент под названием гадолиний, применяющийся для улучшения анализируемости изображений МРТ.
The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.
Критерии включения
- Known or highly suspected central nervous system (CNS) pathology referred for contrast-enhanced MRI of the CNS.
- Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum creatinine result within four weeks prior to the first study MRI.
- Women with negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).Критерии исключения
- No enhancing lesion visible on the gadoterate-enhanced MRI scan.
- Pregnancy or breastfeeding.
- Severe cardiovascular diseaseРезюме исследования
Enrollment Goal
Trial Dates
Phase
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Accepts Healthy Volunteers
Где принять участие
| Местоположения | |
|---|---|
Местоположения Centre Hospitalier Lyon Sud PIERRE BENITE, France, 69495 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения CHU STRASBOURG - Hôpital de Hautepierre STRASBOURG, France, 67098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения A.O.U. Pisana Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Seoul National University Hospital Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Ulsan University Hospital Ulsan, South Korea, 44033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения University of Texas Southwestern Medical Center Dallas, United States, 75390 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Northwestern University Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Mount Sinai Hospital New York City, United States, 10029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения ASL Provincia di Barletta-Andria-Trani Andria, Italy, 70031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Universität Rostock - Medizinische Fakultät Rostock, Germany, 18057 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Universitätsklinikum Schleswig-Holstein / AÖR Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения ULSS2 Marca Trevigiana Treviso, Italy, 31100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Friedrich-Schiller-Uni. Jena Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Universitätsklinikum Schleswig-Holstein (UKSH) Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Kantonsspital Aarau Aarau, Switzerland, 5001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Universitätsklinikum Erlangen Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Royal Preston Hospital Preston, United Kingdom, PR2 4HT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Местоположения Penn State Milton S. Hershey Medical Center Hershey, United States, 17033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Проект исследования
LowEr Administered Dose with highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Н/П
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Degree of lesion contrast enhancementDegree of lesion contrast enhancement is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced).Timeframe: Up to 20 days
- Lesion border delineationLesion border delineation is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded readers scored the delineation of up to 5 lesions using image sequences and a 4-point scale (1 - None = No or unclear delineation; 2 - Moderate = Partial delineation; 3 - Good = Almost clear, but incomplete delineation; 4 - Excellent = Clear and complete delineation).Timeframe: Up to 20 days
- Lesion internal morphologyLesion internal morphology is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored the structure and internal morphology of up to 5 lesions using image sequences and a 3-point scale (1 - Poor = Poor visibility; 2 - Moderate = Partial visibility; 3 - Good = Sufficient visibility)Timeframe: Up to 20 days
Secondary Outcome
- Number of lesions identifiedNumber of lesions identified (up to 10) detected by 3 blinded Readers. The mean (SD) number lesions in the Average Reader for gadobutrol and gadoterate in the Full Analysis Set was reported below.Timeframe: Up to 20 days
- Detection of malignant diseaseThe 3 Blinded Readers had to evaluate if the diagnosis resulting from the combined images was malignant disease or not. Each blinded Reader provided a malignant yes/no response. This was compared to the final diagnosis provided by the Investigator. The majority of Readers (2 or 3 Readers agree) was used to calculate sensitivity, specificity, and accuracy - eg. Final Diagnosis - Malignant (Reader 1-yes, Reader 2-no, Reader 3-yes --- Majority Reader yes) - this would be a match for sensitivity. The percentage of sensitivity, specificity, and accuracy of detection of malignant disease detected by 3 blinded Readers, gadobutrol versus gadoterate (Full Analysis Set) is reported below for Majority Readers.Timeframe: Up to 20 days
- Confidence in diagnosisDiagnostic confidence detected by 3 blinded Readers, gadobutrol vs gadoterate (Full Analysis Set). Blinded Readers rated their confidence in diagnosis according to a 4-point scale (1 - Not confident; 2 - Somewhat confident; 3 - Confident; 4 - Very confident). Results for the Average Reader are reported below.Timeframe: Up to 20 days
- Image qualityComparison of image quality between gadobutrol and gadoterate detected by 3 blinded Readers (Full Analysis Set). Blinded Readers assessed the image quality of gadobutrol- and gadoterate-enhanced images (randomly assigned as left [L] and right [R] image positions) according to a 5-point scale (1- Image R is worse; 2 - Image R is slightly worse; 3- Image R is similar; 4 - Image R is slightly better; 5 - Image R is better). After unblinding of data, the above codes were translated into the following scale: -2 = Gadobutrol image set is worse ; -1 = Gadobutrol image set is slightly worse ; 0 = Image sets are the same ; 1 = Gadobutrol image set is slightly better; 2 = Gadobutrol image set is better. Results for the Average Reader are reported below.Timeframe: Up to 20 days
- Contrast enhancement utilizing an exploratory overall contrast enhancement estimation algorithmComparison of contrast enhancement utilizing an overall contrast enhancement estimation algorithm (Full Analysis Set). The exploratory algorithm analyzed the overall enhancement by comparing the axial T1w (longitudinal relaxation time-weighted) enhanced images to the T1w unenhanced images.Timeframe: Up to 20 days
- Number of participants with treatment-emergent adverse eventsNumber of subjects with treatment-emergent adverse events (TEAEs) (Safety Analysis Set). TEAEs are defined as any AEs that increase in intensity or that are newly developed during the TE period for Study Period 1 or Study Period 2, where TE period for Study Period 1 goes from the first study drug administration in Study Period 1 to 24 hours post-injection, and TE period for Study Period 2 from the first study drug administration in Study Period 2 to 24 hours post-injection.Timeframe: From the first study drug administration up to 24 hours post injection
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