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Trial record 2 of 12 for:    gadoteridol

Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)

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: NCT01613417
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : June 3, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Brain Disease
Interventions Drug: gadoteridol
Drug: gadobutrol
Enrollment 229
Recruitment Details A total of 229 patients were recruited from September 2012 through November 2013 at 19 clinical trial sites. Off-site assessment of the images was performed between 21 January and 3 April 2014 by 3 board-certified neuroradiologists blinded as to which contrast agent was used, patient clinical information, and the results of other imaging studies.
Pre-assignment Details 229 patients were enrolled and signed informed consent. Each enrolled patient was randomized and dosed with at least one contrast agent.
Arm/Group Title Sequence 1 (ProHance Then Gadovist/Gadavist) Sequence 2 (Gadovist/Gadavist Then ProHance)
Hide Arm/Group Description Patients randomized to receive ProHance first Patients randomized to receive Gadovist/Gadavist first
Period Title: First Injection
Started 113 116
Completed 113 116
Not Completed 0 0
Period Title: Washout (no Second Injection/MRI)
Started 113 116
Completed 100 109
Not Completed 13 7
Reason Not Completed
Withdrawal by Subject             13             7
Period Title: Second Injection
Started 100 109
Completed 100 109
Not Completed 0 0
Arm/Group Title ProHance Then Gadovist/Gadavist Gadovist/Gadavist Then ProHance Total
Hide Arm/Group Description Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations Total of all reporting groups
Overall Number of Baseline Participants 93 105 198
Hide Baseline Analysis Population Description
Per Protocol
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 105 participants 198 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
70
  75.3%
70
  66.7%
140
  70.7%
>=65 years
23
  24.7%
35
  33.3%
58
  29.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 105 participants 198 participants
54.5  (14.27) 55.9  (14.29) 55.2  (14.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 105 participants 198 participants
Female
50
  53.8%
58
  55.2%
108
  54.5%
Male
43
  46.2%
47
  44.8%
90
  45.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 105 participants 198 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   3.2%
1
   1.0%
4
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   1.9%
2
   1.0%
White
88
  94.6%
102
  97.1%
190
  96.0%
More than one race
2
   2.2%
0
   0.0%
2
   1.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 105 participants 198 participants
United States 46 46 92
Europe 39 51 90
Canada 8 8 16
1.Primary Outcome
Title Global Diagnostic Preference Between the Two Exams
Hide Description Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame Comparison of image sets obtained within 2 to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
Paired exams reviewed by Reader 1
Paired exams reviewed by Reader 2
Paired exams reviewed by Reader 3
Overall Number of Participants Analyzed 198 194 196
Overall Number of Units Analyzed
Type of Units Analyzed: Patient Exams
198 194 196
Measure Type: Number
Unit of Measure: participant exams
ProHance Preferred 14 7 1
Contrast Agents Equal 171 180 195
Gadovist/Gadavist Preferred 13 7 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.
Statistical Test of Hypothesis P-Value 0.8516
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage PH better minus GV better
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-4.6 to 5.6
Estimation Comments Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage PH better minus GV better
Estimated Value 0
Confidence Interval (2-Sided) 95%
-3.8 to 3.8
Estimation Comments Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage PH better minus GV better
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.5 to 1.5
Estimation Comments Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)
2.Secondary Outcome
Title Lesion Border Delineation
Hide Description Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame Comparison of image sets obtained within 2 to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
Paired exams reviewed by Reader 1
Paired exams reviewed by Reader 2
Paired exams reviewed by Reader 3
Overall Number of Participants Analyzed 198 194 196
Overall Number of Units Analyzed
Type of Units Analyzed: Patient Exams
198 194 196
Measure Type: Number
Unit of Measure: participant exams
ProHance Better 8 2 1
No Difference between Prohance and Gadovist/Gadavi 181 189 195
Gadovist/Gadavist Better 9 3 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Lesion Internal Morphology
Hide Description Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame Comparison of image sets obtained within 2 to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
Paired exams reviewed by Reader 1
Paired exams reviewed by Reader 2
Paired exams reviewed by Reader 3
Overall Number of Participants Analyzed 198 198 198
Overall Number of Units Analyzed
Type of Units Analyzed: Patient Exams
198 194 196
Measure Type: Number
Unit of Measure: participant exams
ProHance better 2 2 1
No Difference Between ProHance and Gadovist/Gadavi 195 188 195
Gadovist/Gadavist betterB 1 4 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6875
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Extent of Disease
Hide Description Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame Comparison of image sets obtained within 2 to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
Paired exams reviewed by Reader 1
Paired exams reviewed by Reader 2
Paired exams reviewed by Reader 3
Overall Number of Participants Analyzed 198 198 198
Overall Number of Units Analyzed
Type of Units Analyzed: Patient Exams
198 194 196
Measure Type: Number
Unit of Measure: participant exams
ProHance Better 1 2 1
No Difference between ProHance and Gadovist/Gadavi 196 190 195
Gadovist/Gadavist Better 1 2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Lesion Contrast Enhancement
Hide Description Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Time Frame Comparison of image sets obtained within 2 to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
Paired exams reviewed by Reader 1
Paired exams reviewed by Reader 2
Paired exams reviewed by Reader 3
Overall Number of Participants Analyzed 198 198 198
Overall Number of Units Analyzed
Type of Units Analyzed: Patient Exams
198 194 196
Measure Type: Number
Unit of Measure: participant exams
ProHance Better 14 10 2
No Difference between ProHance and Gadovist/Gadavi 170 174 193
Gadovist/Gadavist Better 14 10 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value from Wilcoxon signed-rank test
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Lesion to Background Ratio on Post T1-weighed Spin Echo Images
Hide Description Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)
Time Frame 5-10 minutes Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
Lesions reviewed by Reader 1
Lesions reviewed by Reader 2
Lesions reviewed by Reader 3
Overall Number of Participants Analyzed 198 194 196
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
194 137 162
Mean (Standard Deviation)
Unit of Measure: signal intensity
-0.02  (0.17) -0.16  (1.12) -0.01  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2758
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0676
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5267
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect
7.Secondary Outcome
Title Percentage Signal Intensity Enhancement on Postdose Images
Hide Description Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)
Time Frame 5-10 minutes Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
Lesions reviewed by Reader 1
Lesions reviewed by Reader 2
Lesions reviewed by Reader 3
Overall Number of Participants Analyzed 198 194 196
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
191 133 159
Mean (Standard Deviation)
Unit of Measure: percentage signal intensity enhancement
1.06  (28.61) -2.09  (29.06) -1.59  (29.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6201
Comments [Not Specified]
Method Mixed Models Analysis
Comments Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4514
Comments [Not Specified]
Method Mixed Models Analysis
Comments Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7722
Comments [Not Specified]
Method Mixed Models Analysis
Comments Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.
8.Secondary Outcome
Title Lesion Detection
Hide Description Lesion detection rate by contrast agent and reader
Time Frame 5-10 minutes Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol patients with histologically confirmed lesions
Arm/Group Title Reader 1 - ProHance Reader 1 - Gadovist/Gadavist Reader 2 - ProHance Reader 2 - Gadovist/Gadavist Reader 3 - ProHance Reader 3 - Gadovist/Gadavist
Hide Arm/Group Description:
MRI after ProHance 0.1 mmol/kg
MRI after Gadovist/Gadavist 0.1 mmol/kg
MRI after ProHance 0.1 mmol/kg
MRI after Gadovist/Gadavist 0.1 mmol/kg
MRI after ProHance 0.1 mmol/kg
MRI after Gadovist/Gadavist 0.1 mmol/kg
Overall Number of Participants Analyzed 139 139 139 139 139 139
Measure Type: Number
Unit of Measure: participant exams
True Positive (Patients) 133 135 137 136 136 132
False Negative (Pa 6 4 2 3 3 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1 - ProHance, Reader 1 - Gadovist/Gadavist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3173
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2 - ProHance, Reader 2 - Gadovist/Gadavist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5637
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3 - ProHance, Reader 3 - Gadovist/Gadavist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0455
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
9.Secondary Outcome
Title Accuracy for Tumor Characterization
Hide Description Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment
Time Frame 5-10 minutes Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with histologically confirmed lesions
Arm/Group Title Reader 1 - ProHance Reader 1 - Gadovist/Gadavist Reader 2 - ProHance Reader 2 - Gadovist/Gadavist Reader 3 - ProHance Reader 3 - Gadovist/Gadavist
Hide Arm/Group Description:
MRI after ProHance 0.1 mmol/kg
MRI after Gadovist/Gadavist 0.1 mmol/kg
MRI after ProHance 0.1 mmol/kg
MRI after Gadovist/Gadavist 0.1 mmol/kg
MRI after ProHance 0.1 mmol/kg
MRI after Gadovist/Gadavist 0.1 mmol/kg
Overall Number of Participants Analyzed 128 128 128 128 128 128
Measure Type: Number
Unit of Measure: participants
Patients with Tumors Correctly Categorized 94 96 106 101 93 83
Patients with Tumors Incorrectly Categorized 34 32 22 27 35 45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1 - ProHance, Reader 1 - Gadovist/Gadavist
Comments McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6949
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 2 - ProHance, Reader 2 - Gadovist/Gadavist
Comments McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1317
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 3 - ProHance, Reader 3 - Gadovist/Gadavist
Comments McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0124
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Time Frame Up to 24 hours after contrast media injection
Adverse Event Reporting Description All adverse events collected were categorized using MedDRA 16.1 and tabulated
 
Arm/Group Title Safety Population (ProHance) Safety Population (Gadovist/Gadavist)
Hide Arm/Group Description All enrolled patients who received a randomized injection of ProHance All enrolled patients who received a randomized injection of Gadovist/Gadavist
All-Cause Mortality
Safety Population (ProHance) Safety Population (Gadovist/Gadavist)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Safety Population (ProHance) Safety Population (Gadovist/Gadavist)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/222 (0.00%)   0/216 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Safety Population (ProHance) Safety Population (Gadovist/Gadavist)
Affected / at Risk (%) Affected / at Risk (%)
Total   15/222 (6.76%)   8/216 (3.70%) 
Gastrointestinal disorders     
Diarrhea  1  1/222 (0.45%)  0/216 (0.00%) 
Nausea  1  4/222 (1.80%)  1/216 (0.46%) 
Vomiting  1  1/222 (0.45%)  1/216 (0.46%) 
Fatigue  1  0/222 (0.00%)  1/216 (0.46%) 
General disorders     
Feeling hot  1  1/222 (0.45%)  0/216 (0.00%) 
Nervous system disorders     
Convulsion  1  0/222 (0.00%)  1/216 (0.46%) 
Dizziness  1  1/222 (0.45%)  1/216 (0.46%) 
Dysgeusia  1  4/222 (1.80%)  1/216 (0.46%) 
Headache  1  2/222 (0.90%)  1/216 (0.46%) 
Lethargy  1  1/222 (0.45%)  0/216 (0.00%) 
Migraine  1  1/222 (0.45%)  0/216 (0.00%) 
Paresthesia  1  0/222 (0.00%)  1/216 (0.46%) 
Psychiatric disorders     
Anxiety  1  0/222 (0.00%)  1/216 (0.46%) 
Mood altered  1  0/222 (0.00%)  1/216 (0.46%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/222 (0.90%)  0/216 (0.00%) 
Dyspnea  1  1/222 (0.45%)  0/216 (0.00%) 
Orophanyngeal pain  1  0/222 (0.00%)  1/216 (0.46%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  1/222 (0.45%)  0/216 (0.00%) 
Rash  1  1/222 (0.45%)  0/216 (0.00%) 
Urticaria  1  1/222 (0.45%)  0/216 (0.00%) 
Vascular disorders     
Vascular rupture  1  1/222 (0.45%)  0/216 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Histologic confirmation of disease available for only 139/198 patients in the PP analysis. Of these, 128 patients had confirmed brain tumors and were available for the analyses of diagnostic performance (tumor detection and tumor characterization).
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.
Study results may be presented at scientific symposia or published in a peer-review journal after review by sponsor in accordance with the guidelines set forth in the applicable publication or financial agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gianpaolo Pirovano, MD
Organization: Executive Director, MRI
Phone: 609-514-2226
EMail: gianpaolo.pirovano@diag.bracco.com
Layout table for additonal information
Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01613417     History of Changes
Other Study ID Numbers: PH-107
First Submitted: June 4, 2012
First Posted: June 7, 2012
Results First Submitted: April 28, 2015
Results First Posted: June 3, 2015
Last Update Posted: July 1, 2015