Trial Outcomes & Findings for Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors (NCT NCT02034708)
NCT ID: NCT02034708
Last Updated: 2016-12-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
279 participants
Primary outcome timeframe
Up to 15 days after randomization
Results posted on
2016-12-30
Participant Flow
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.
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 From these 279 patients, 11 did not receive any injection : 4 for consent withdrawn, 3 for deviation from plan specified in the protocol, 2 for adverse events, 1 at the investigator's discretion and 1 for other reason.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Contrast Agent Injection (1 Day)
STARTED
|
138
|
130
|
|
First Contrast Agent Injection (1 Day)
COMPLETED
|
138
|
130
|
|
First Contrast Agent Injection (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Wash-out (From 2 Days up to 14 Days)
STARTED
|
138
|
130
|
|
Wash-out (From 2 Days up to 14 Days)
COMPLETED
|
129
|
120
|
|
Wash-out (From 2 Days up to 14 Days)
NOT COMPLETED
|
9
|
10
|
|
Second Contrast Agent Injection (1 Day)
STARTED
|
129
|
120
|
|
Second Contrast Agent Injection (1 Day)
COMPLETED
|
129
|
120
|
|
Second Contrast Agent Injection (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Wash-out (From 2 Days up to 14 Days)
Withdrawal by Subject
|
2
|
5
|
|
Wash-out (From 2 Days up to 14 Days)
Adverse Event
|
1
|
0
|
|
Wash-out (From 2 Days up to 14 Days)
Protocol Violation
|
3
|
3
|
|
Wash-out (From 2 Days up to 14 Days)
other reason
|
3
|
2
|
Baseline Characteristics
Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Baseline characteristics by cohort
| Measure |
Dotarem®/Gadovist®
n=138 Participants
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®/Dotarem®
n=130 Participants
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
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Gender
Female
|
87 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Gender
Male
|
51 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
40 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
52 participants
n=5 Participants
|
51 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Body Mass Index
|
27.71 kg per square metre
STANDARD_DEVIATION 5.35 • n=5 Participants
|
27.62 kg per square metre
STANDARD_DEVIATION 5.23 • n=7 Participants
|
27.66 kg per square metre
STANDARD_DEVIATION 5.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 15 days after randomizationPopulation: Patients with at least one valid assessment of the primary outcome and without major protocol deviation
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.
Outcome measures
| Measure |
Gadovist® (Reader 1)
n=234 Participants
Patients who received Gadovist® Results for reader 1
|
Dotarem® (Reader 1)
n=234 Participants
Patients who received Dotarem® Results for reader 1
|
Gadovist® (Reader 2)
n=234 Participants
Patients who received Gadovist® Results for reader 2
|
Dotarem® (Reader 2)
n=234 Participants
Patients who received Dotarem® Results for reader 2
|
Gadovist® (Reader 3)
n=234 Participants
Patients who received Gadovist® Results for reader 3
|
Dotarem® (Reader 3)
n=234 Participants
Patients who received Dotarem® Results for reader 3
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent
|
94.0 percentage of patients
|
96.2 percentage of patients
|
93.2 percentage of patients
|
90.6 percentage of patients
|
99.6 percentage of patients
|
100.0 percentage of patients
|
Adverse Events
Dotarem®
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Gadovist®
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dotarem®
n=258 participants at risk
Patients who received Dotarem®
|
Gadovist®
n=259 participants at risk
Patients who received Gadovist®
|
Total
n=268 participants at risk
Patients who received at least one injection of contrast agent
|
|---|---|---|---|
|
General disorders
Aggravation of existing disorder
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Nervous system disorders
Coma
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
Other adverse events
| Measure |
Dotarem®
n=258 participants at risk
Patients who received Dotarem®
|
Gadovist®
n=259 participants at risk
Patients who received Gadovist®
|
Total
n=268 participants at risk
Patients who received at least one injection of contrast agent
|
|---|---|---|---|
|
General disorders
Injection site pain
|
4.7%
12/258 • Number of events 12 • From patient inclusion up to 30 min after last contrast agent injection
|
4.6%
12/259 • Number of events 13 • From patient inclusion up to 30 min after last contrast agent injection
|
7.5%
20/268 • Number of events 25 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Medical device pain
|
5.8%
15/258 • Number of events 15 • From patient inclusion up to 30 min after last contrast agent injection
|
6.6%
17/259 • Number of events 17 • From patient inclusion up to 30 min after last contrast agent injection
|
6.3%
17/268 • Number of events 32 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Injection site coldness
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.75%
2/268 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Injection site paraesthesia
|
0.78%
2/258 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.75%
2/268 • Number of events 3 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Catheter site related reaction
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Chest pain
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Drug ineffective
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Feeling cold
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Feeling hot
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Injection site erythema
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Injection site inflammation
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Injection site rash
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
General disorders
Injection site reaction
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Nervous system disorders
Headache
|
1.6%
4/258 • Number of events 4 • From patient inclusion up to 30 min after last contrast agent injection
|
1.2%
3/259 • Number of events 3 • From patient inclusion up to 30 min after last contrast agent injection
|
2.6%
7/268 • Number of events 7 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Nervous system disorders
Dizziness
|
0.78%
2/258 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
1.5%
4/259 • Number of events 4 • From patient inclusion up to 30 min after last contrast agent injection
|
1.9%
5/268 • Number of events 6 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Nervous system disorders
Paraesthesia
|
0.78%
2/258 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.75%
2/268 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Nervous system disorders
Hypoaesthesia
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Gastrointestinal disorders
Nausea
|
0.78%
2/258 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
1.2%
3/259 • Number of events 3 • From patient inclusion up to 30 min after last contrast agent injection
|
1.9%
5/268 • Number of events 5 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.75%
2/268 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Investigations
Blood pressure increased
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.77%
2/259 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
0.75%
2/268 • Number of events 2 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/258 • From patient inclusion up to 30 min after last contrast agent injection
|
0.39%
1/259 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Eye disorders
Eye swelling
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Infections and infestations
Pharyngitis
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
|
Vascular disorders
Hot flush
|
0.39%
1/258 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
0.00%
0/259 • From patient inclusion up to 30 min after last contrast agent injection
|
0.37%
1/268 • Number of events 1 • From patient inclusion up to 30 min after last contrast agent injection
|
Additional Information
Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical
Guerbet
Phone: +33 (0) 1 45 91 51 84
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER