Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors (REMIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034708
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : October 25, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Primary Brain Tumor
Interventions Drug: Dotarem®
Drug: Gadovist®/Gadavist®
Enrollment 279
Recruitment Details 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.
Pre-assignment Details 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 From these 279 patients, 11 did not receive any injection : 4 for consent withdrawn, 3 for deviation from plan specified in the protocol, 2 for adverse events, 1 at the investigator's discretion and 1 for other reason.
Arm/Group Title Dotarem®/Gadovist® Gadovist®/Dotarem®
Hide Arm/Group Description

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.

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.

Period Title: First Contrast Agent Injection (1 Day)
Started 138 130
Completed 138 130
Not Completed 0 0
Period Title: Wash-out (From 2 Days up to 14 Days)
Started 138 130
Completed 129 120
Not Completed 9 10
Reason Not Completed
Withdrawal by Subject             2             5
Adverse Event             1             0
Protocol Violation             3             3
other reason             3             2
Period Title: Second Contrast Agent Injection (1 Day)
Started 129 120
Completed 129 120
Not Completed 0 0
Arm/Group Title Dotarem®/Gadovist® Gadovist®/Dotarem® Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 138 130 268
Hide Baseline Analysis Population Description
All patients receiving at least one injection of contrast agent and with one valid assessment of the primary outcome
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 130 participants 268 participants
52.9  (15.2) 54.4  (15.1) 53.6  (15.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 130 participants 268 participants
Female
87
  63.0%
85
  65.4%
172
  64.2%
Male
51
  37.0%
45
  34.6%
96
  35.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 138 participants 130 participants 268 participants
Colombia 16 16 32
United States 46 40 86
Korea, Republic of 24 23 47
Mexico 52 51 103
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg per square metre
Number Analyzed 138 participants 130 participants 268 participants
27.71  (5.35) 27.62  (5.23) 27.66  (5.28)
1.Primary Outcome
Title Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent
Hide Description

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.

Time Frame Up to 15 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with at least one valid assessment of the primary outcome and without major protocol deviation
Arm/Group Title Gadovist® (Reader 1) Dotarem® (Reader 1) Gadovist® (Reader 2) Dotarem® (Reader 2) Gadovist® (Reader 3) Dotarem® (Reader 3)
Hide Arm/Group Description:
Patients who received Gadovist® Results for reader 1
Patients who received Dotarem® Results for reader 1
Patients who received Gadovist® Results for reader 2
Patients who received Dotarem® Results for reader 2
Patients who received Gadovist® Results for reader 3
Patients who received Dotarem® Results for reader 3
Overall Number of Participants Analyzed 234 234 234 234 234 234
Measure Type: Number
Unit of Measure: percentage of patients
94.0 96.2 93.2 90.6 99.6 100.0
Time Frame From patient inclusion up to 30 min after last contrast agent injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dotarem® Gadovist® Total
Hide Arm/Group Description Patients who received Dotarem® Patients who received Gadovist® Patients who received at least one injection of contrast agent
All-Cause Mortality
Dotarem® Gadovist® Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Dotarem® Gadovist® Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/258 (0.39%)      0/259 (0.00%)      1/268 (0.37%)    
General disorders       
Aggravation of existing disorder  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Nervous system disorders       
Coma  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dotarem® Gadovist® Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/258 (16.28%)      44/259 (16.99%)      63/268 (23.51%)    
Cardiac disorders       
Bradycardia  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Eye disorders       
Eye swelling  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Gastrointestinal disorders       
Nausea  1  2/258 (0.78%)  2 3/259 (1.16%)  3 5/268 (1.87%)  5
Infrequent bowel movements  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Vomiting  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
General disorders       
Injection site pain  1  12/258 (4.65%)  12 12/259 (4.63%)  13 20/268 (7.46%)  25
Medical device pain  1  15/258 (5.81%)  15 17/259 (6.56%)  17 17/268 (6.34%)  32
Injection site coldness  1  1/258 (0.39%)  1 1/259 (0.39%)  1 2/268 (0.75%)  2
Injection site paraesthesia  1  2/258 (0.78%)  2 1/259 (0.39%)  1 2/268 (0.75%)  3
Catheter site related reaction  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Chest pain  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Drug ineffective  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Feeling cold  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Feeling hot  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Injection site erythema  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Injection site inflammation  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Injection site rash  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Injection site reaction  1  1/258 (0.39%)  1 1/259 (0.39%)  1 1/268 (0.37%)  2
Infections and infestations       
Pharyngitis  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Investigations       
Blood pressure increased  1  0/258 (0.00%)  0 2/259 (0.77%)  2 2/268 (0.75%)  2
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  1/258 (0.39%)  1 1/259 (0.39%)  1 2/268 (0.75%)  2
Back pain  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Neck pain  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Nervous system disorders       
Headache  1  4/258 (1.55%)  4 3/259 (1.16%)  3 7/268 (2.61%)  7
Dizziness  1  2/258 (0.78%)  2 4/259 (1.54%)  4 5/268 (1.87%)  6
Paraesthesia  1  2/258 (0.78%)  2 0/259 (0.00%)  0 2/268 (0.75%)  2
Hypoaesthesia  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Skin and subcutaneous tissue disorders       
Dermatosis  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Rash  1  0/258 (0.00%)  0 1/259 (0.39%)  1 1/268 (0.37%)  1
Vascular disorders       
Hot flush  1  1/258 (0.39%)  1 0/259 (0.00%)  0 1/268 (0.37%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical
Organization: Guerbet
Phone: +33 (0) 1 45 91 51 84
EMail: corinne.dubourdieu@guerbet-group.com
Layout table for additonal information
Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT02034708    
Other Study ID Numbers: DGD-44-058
First Submitted: January 10, 2014
First Posted: January 13, 2014
Results First Submitted: September 2, 2016
Results First Posted: October 25, 2016
Last Update Posted: December 30, 2016