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The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment).
270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between.
Each patient will, therefore, receive two MRI during his/her participation in the study.
The two arms consist in :
Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems.
MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem®/Gadovist® | Experimental | Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI |
|
| Gadovist®/Dotarem® | Experimental | Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotarem® | Drug | Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent | Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale: 0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion. | Up to 15 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Maravilla, MD | University of Washington Medical Center, Seattle, USA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| University of Arizona Medical Center |
279 patients signed an informed consent for the study and therefore were considered as included. From these 279 patients, 11 did not receive any injection : 4 for consent withdrawn, 3 for deviation from plan specified in the protocol, 2 for adverse events, 1 at the investigator's discretion and 1 for other reason.
Adult patients with known or highly suspected primary intracranial tumors and scheduled for a Dotarem®-enhanced MRI were recruited in 27 active centers in 4 countries (Colombia, South Korea, Mexico and United States) from June 2014 to September 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dotarem®/Gadovist® | Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus. |
| FG001 | Gadovist®/Dotarem® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Contrast Agent Injection (1 Day) |
|
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| Gadovist®/Gadavist® | Drug | Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus. |
|
| Tucson |
| Arizona |
| AZ 85724 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | United States |
| Yale University School Of Medicine | New Haven | Connecticut | United States |
| Infinity Clinical Research, LLC | Hollywood | Florida | FL 33021 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | United States |
| Quest Research Institute | Farmington Hills | Michigan | United States |
| Spectrum Health | Grand Rapids | Michigan | United States |
| Washington University | St Louis | Missouri | United States |
| Winthrop University Hospital Clinical Trials Center | Mineola | New York | NY 11501 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | United States |
| MUSC (Medical University of South Carolina) | Charleston | South Carolina | United States |
| UVM MRI Center for Biomedical Imaging | Burlington | Vermont | United States |
| University of Washington Medical Center | Seattle | Washington | United States |
| Fundacion Abood Shaio | Bogotá | Colombia |
| Fundacion Cardioinfantil Instituto de Cardiologia | Bogotá | Colombia |
| Instituto Nacional de Cancerologia | Bogotá | Colombia |
| Centro Medico Imbanaco | Cali | Colombia |
| Fundacion Instituto de Alta Tecnologia Medica de Antioquia IATM | Medellín | Colombia |
| Hospital Pablo Tobon Uribe | Medellín | Colombia |
| Hospital CIMA | Chihuahua City | Chihuahua | 31238 | Mexico |
| Morales Vargas Centro de Investigación S.C. | León | Guanajuato | 37000 | Mexico |
| Centro Neurologico ABC | México | Mexico Distrito Federal | 5300 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64020 | Mexico |
| Winsett Rethman S.A. de C.V. | Monterrey | Nuevo León | Mexico |
| Centro Regiomontano de Investigacion S.C. | Monterrey | Mexico |
| Clinical Research Institute S.C. | Tlanepantla | Mexico |
| Chonbuk national Univ Hosp | Jeonju | Jeollabuk-do | 561-712 | South Korea |
| Chungbuk National University | Cheongju-si | North Chungcheong | 361-711 | South Korea |
| Seoul St.Mary Hospital | Seoul | Seocho-gu | 137-701 | South Korea |
| Asan medical center | Seoul | Songpa-Gu | 138-736 | South Korea |
| Ajou University Hospital | Suwon | South Korea |
Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus. |
| COMPLETED |
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| NOT COMPLETED |
|
| Wash-out (From 2 Days up to 14 Days) |
|
|
| Second Contrast Agent Injection (1 Day) |
|
All patients receiving at least one injection of contrast agent and with one valid assessment of the primary outcome
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| ID | Title | Description |
|---|---|---|
| BG000 | Dotarem®/Gadovist® | Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus. |
| BG001 | Gadovist®/Dotarem® | Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg per square metre |
|
| 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 | Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent | Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale: 0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion. | Patients with at least one valid assessment of the primary outcome and without major protocol deviation | Posted | Number | percentage of patients | Up to 15 days after randomization |
|
|
|
From patient inclusion up to 30 min after last contrast agent injection
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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® | Patients who received Dotarem® | 1 | 258 | 42 | 258 | ||
| EG001 | Gadovist® | Patients who received Gadovist® | 0 | 259 | 44 | 259 | ||
| EG002 | Total | Patients who received at least one injection of contrast agent | 1 | 268 | 63 | 268 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aggravation of existing disorder | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site coldness | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
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| Eye swelling | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
Each investigator agrees not to publish/present the results of the study main criterion involving only the patients included in his/her center. Publications on specific topics can be performed only after main publication.The sponsor can review the publication at least 30 days before the submission to the scientific review and any abstract project at least 10 working days before submission to the congress scientific committee. The sponsor can require changes to the publication or the abstract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical | Guerbet | +33 (0) 1 45 91 51 84 | corinne.dubourdieu@guerbet-group.com |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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| Protocol Violation |
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| other reason |
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| Male |
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| United States |
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| Korea, Republic of |
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| Mexico |
|