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The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® 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 Dotarem®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem (gadoterate meglumine ) | Experimental | Dotarem and Magnevist were randomised as 2:1 ratio for adult patients. |
|
| Magnevist (gadopentetate dimeglumine) | Active Comparator | Dotarem and Magnevist were randomised as 2:1 ratio |
|
| Dotarem 2 (gadoterate meglumine ) | Experimental | Pediatric patients were assigned to Dotarem group only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotarem (gadoterate meglumine) | Drug | 0.1 mmol/kg by body weight, single IV injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation | To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization. Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI. The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality Score | Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality. | up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Maravilla, MD | University of Wasington School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, UABMC | Birmingham | Alabama | 35233 | United States | ||
| University Medical Center |
Any patient who did not fulfill eligibility criteria was not randomized / assigned to a treatment group.
First patient First Visit : 16 Sept 2010 Last patient Last Visit : 16 Nov 2011 Locations: radiology departments
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| ID | Title | Description |
|---|---|---|
| FG000 | Dotarem (Gadoterate Meglumine) | Dotarem and Magnevist were randomised as 2:1 ratio for adult patients. |
| FG001 | Magnevist (Gadopentetate Dimeglumine) | Dotarem and Magnevist were randomised as 2:1 ratio |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Magnevist (gadopentetate dimeglumine) | Drug | 0.1 mmol/kg by body weight, single IV injection |
|
|
| Diagnostic Confidence Score |
Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5). |
| up to 24 hours |
| Number of Lesions | The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient | up to 24 hours |
| Tucson |
| Arizona |
| 47404 |
| United States |
| University medical center | Tucson | Arizona | 85724 | United States |
| Desert Medical Imaging | Indian Wells | California | 47404 | United States |
| Sunrise Clinical Research, Inc. | Hollywood | Florida | 33021 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States |
| Precise Clinical Research Solutions | Topeka | Kansas | 66604 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Neurocare Center for Research | Brookline | Massachusetts | 02446 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Gruss Magnetic resonance Research Clinic | New York | New York | 10461 | United States |
| WestImage - Division of Research | Cincinnati | Ohio | 45248 | United States |
| Ohio State University | Columbus | Ohio | 47404 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas - Health Science Center | San Antonio | Texas | 47404 | United States |
| UTHSCSA | San Antonio | Texas | 47404 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Centro de Diagnóstico | Buenos Aires | Argentina |
| Hospital Italiano | Buenos Aires | Argentina |
| TCBA | Buenos Aires | Argentina |
| Univ.-institut f.Radiodiagnostik | Salzburg | Austria |
| Landesklinikum Tulln | Tulln | Austria |
| Medical University of Vienna | Vienna | Austria |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | Brazil |
| Universidade Federal de São Paulo / UNIFESP | São Paulo | Brazil |
| Departamento de Neuroradiologia | Santiago | Chile |
| Instituto de Neurocirugia Dr. Asenjo, | Santiago | Chile |
| Hôpital Pellegrin | Bordeaux | France |
| Hôpital Roger Salengro- CRHU de Lille | Lille | France |
| Hôpital Gui De Chauliac | Montpellier | France |
| Centre Hospitalier Sainte Anne | Paris | France |
| Radiologie A - Hôpital de la Milétrie | Poitiers | France |
| Fédération d'Imagerie Médicale,Hôpital Pontchaillou | Rennes | France |
| University Hospital Charite | Berlin | Germany |
| Krankenhaus Nordwest GmbH | Frankfurt | Germany |
| University Hospital Frankfurt | Frankfurt am Main | Germany |
| University of Heidelberg | Heidelberg | Germany |
| University of Leipzig | Leipzig | Germany |
| University Hospital Mannheim | Mannheim | Germany |
| University Hospital LMU Munich | Munich | Germany |
| Istituto di Radiologia | Florence | Italy |
| Neuroradiologia,II Università Di Napoli | Naples | Italy |
| Azienda Ospedaliera S. Andrea | Roma | Italy |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National Unversity Hospital | Seoul | South Korea |
| Hospital Vall d´Hebron | Barcelona | Spain |
| Hospital Clinico Universitario San Carlos | Madrid | Spain |
| Complejo Hospitalario Universitario de Vigo - Serviço de radiologia | Vigo | Spain |
| University Department of Radiology | Cambridge | United Kingdom |
| FG002 | Dotarem 2 (Gadoterate Meglumine) | Pediatric patients were assigned to Dotarem group only |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnevist (Gadopentetate Dimeglumine) | adults received Magnevist as 1:2 ratio compared to Dotarem |
| BG001 | Dotarem (Gadoterate Meglumine) | adults received Dotarem as 2:1 ratio compared to Magnevist. |
| BG002 | Dotarem 2 (Gadoterate Meglumine) | All children were assigned to Dotarem |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation | To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization. Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI. The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0. | The primary analysis was performed at the patient level using off-site readings by 3 readers. The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants were included in this data set. | Posted | Mean | Standard Deviation | units on a scale | up to 24 hours |
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| Secondary | Image Quality Score | Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality. | The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants are included in this data set. | Posted | Mean | Standard Deviation | units on a scale | up to 24 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diagnostic Confidence Score | Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5). | The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants are included in this data set. | Posted | Mean | Standard Deviation | units on a scale | up to 24 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Lesions | The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient | The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants are included in this data set. | Posted | Mean | Standard Deviation | Number of lesions | up to 24 hours |
|
Adverse events were collected from patient consent signature to the end of the last visits, maximum duration is 29 days.
Participants at risk were subjects exposed to contrast agent administration. In Dotarem group, 240 adults were injected, Dotarem group 2, 38 children were injected (2 children were withdrawn after agent administration) and in Magnevist group, 117 adults were injected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dotarem (Gadoterate Meglumine ) | Dotarem and Magnevist were randomised as 2:1 ratio for adults | 0 | 240 | 0 | 240 | 12 | 240 |
| EG001 | Magnevist (Gadopentetate Dimeglumine) | Dotarem and Magnevist were randomised as 2:1 ratio | 0 | 117 | 1 | 117 | 9 | 117 |
| EG002 | Dotarem 2 (Gadoterate Meglumine ) | children were only assigned to Dotarem | 0 | 38 | 1 | 38 | 8 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| small intestine perforation | Gastrointestinal disorders | Systematic Assessment | not related |
| |
| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | not related |
| |
| neurological decompensation | Nervous system disorders | Systematic Assessment | not related |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site pain | General disorders | Systematic Assessment |
| ||
| injection site hematoma | General disorders | Systematic Assessment |
| ||
| extravasation | General disorders | Systematic Assessment |
| ||
| chest pain | General disorders | Systematic Assessment |
| ||
| blood urine present | Investigations | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
| ||
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| asthenia | General disorders | Systematic Assessment |
| ||
| application site erythema | General disorders | Systematic Assessment |
| ||
| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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No unpublished data given to the investigator may be transmitted to a third party without prior approval of the sponsor in writing. The data are the exclusive property of Guerbet.
The investigator undertakes to submit to Guerbet any draft articles or papers related to this study within 30 days of their submission to the scientific review or the congress scientific committee.
All written or oral papers and publications must have the joint agreement of the investigator and the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jing Hao, MD | Guerbet | +33145915000 | jing.hao@guerbet.com |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| France |
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| Argentina |
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| Brazil |
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| Spain |
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| Austria |
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| Chile |
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| Germany |
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| United Kingdom |
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| Italy |
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| Korea, Republic of |
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| Border Delineation Blinded Reader 3 |
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| Internal Morphology Blinded Reader 1 |
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| Internal Morphology Blinded Reader 2 |
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| Internal Morphology Blinded Reader 3 |
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| Contrast Enhancement Blinded Reader 1 |
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| Contrast Enhancement Blinded Reader 2 |
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| Contrast Enhancement Blinded Reader 3 |
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All sequences pre- and post-injection of Magnevist were pooled as PAIRED
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