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Trial record 3 of 12 for:    gadoteridol

SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

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ClinicalTrials.gov Identifier: NCT00522951
Recruitment Status : Completed
First Posted : August 30, 2007
Results First Posted : August 3, 2011
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Condition Brain Metastases
Interventions Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Drug: ProHance
Enrollment 165
Recruitment Details  
Pre-assignment Details A total of 175 participants were enrolled into the study. 10 were withdrawn from the study before entering Study Period 1. Safety Analysis Set included 164 participants; gadobutrol=161, ProHance=162. Per Protocol Set (PPS) included 151 participants.
Arm/Group Title Gadobutrol Then Gadoteridol Gadoteridol Then Gadobutrol
Hide Arm/Group Description Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2 Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
Period Title: Period 1
Started 86 79
Received Treatment 86 78
Completed 86 78
Not Completed 0 1
Reason Not Completed
body motion             0             1
Period Title: Washout Period
Started 86 78
Completed 86 76
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Death             0             1
Period Title: Period 2
Started 86 76
Subjects Received Treatment 84 75
Completed 84 75
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             0
residual contrast medium             1             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description includes all participants received treatment
Overall Number of Baseline Participants 164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants
61.7  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants
Female
74
  45.1%
Male
90
  54.9%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 164 participants
160.9  (8.7)
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 164 participants
56.7  (12.2)
Primary focus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants
Lung cancer 123
Breast cancer 20
Others 21
1.Primary Outcome
Title Number of Lesions Detected by Blinded Readers (BR) and Investigator
Hide Description Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 151 151 151
Mean (Standard Deviation)
Unit of Measure: lesions
averaged blinded reader 6.28  (8.31) 6.92  (8.69) 6.87  (8.65)
investigator 6.36  (8.26) 6.87  (8.49) 6.66  (8.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol 0.1 mmol/kg bw, Gadoteridol (ProHance) 0.2mmol/kg bw
Comments H01: μG1 – μPr ≤ -1
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority margin = -1
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.58
Confidence Interval 95%
-0.87 to -0.29
Estimation Comments Averaged blinded reader (primary analysis)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol 0.2 mmol/kg bw, Gadoteridol (ProHance) 0.2mmol/kg bw
Comments H02: μG2 – μPr ≤ -1
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority margin = -1
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval 95%
-0.23 to 0.36
Estimation Comments Averaged blinded reader (primary analysis)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Gadobutrol 0.1 mmol/kg bw, Gadoteridol (ProHance) 0.2mmol/kg bw
Comments H01: μG1 – μPr ≤ -1
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority margin = -1
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.5 to -0.1
Estimation Comments Investigator (secondary analysis)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gadobutrol 0.2 mmol/kg bw, Gadoteridol (ProHance) 0.2mmol/kg bw
Comments H02: μG2 – μPr ≤ -1
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority margin = -1
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval 95%
0.02 to 0.41
Estimation Comments Investigator (secondary analysis)
2.Secondary Outcome
Title Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
Hide Description Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 143 148 149
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.44  (0.42) 3.54  (0.44) 3.51  (0.49)
3.Secondary Outcome
Title Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
Hide Description Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 143 143 144
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.16  (0.63) 3.46  (0.55) 3.31  (0.63)
4.Secondary Outcome
Title Score of Visibility Assessment - Border Delineation by Blinded Reader
Hide Description Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 143 148 149
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.30  (0.46) 3.45  (0.48) 3.36  (0.56)
5.Secondary Outcome
Title Score of Visibility Assessment - Border Delineation by Investigator
Hide Description Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 143 143 144
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.10  (0.70) 3.38  (0.61) 3.22  (0.68)
6.Secondary Outcome
Title Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
Hide Description Treatment planning confidence evaluated separately for each image set (gadobutrol [Gado-] 0.1 mmol/kg bw and gadoteridol [Pro-] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: participants
Gado-not confident, Pro-not confident 0
Gado-not confident, Pro-confident 2
Gado-not confident, Pro-not assessable 0
Gado-confident, Pro-not confident 1
Gado-confident, Pro-confident 148
Gado-confident, Pro-not assessable 0
Gado-not assessable, Pro-not confident 0
Gado-not assessable, Pro-confident 0
Gado-not assessable, Pro-not assessable 0
7.Secondary Outcome
Title Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Hide Description Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: participants
Gado-not confident, Pro-not confident 1
Gado-not confident, Pro-confident 0
Gado-not confident, Pro-not assessable 0
Gado-confident, Pro-not confident 0
Gado-confident, Pro-confident 149
Gado-confident, Pro-not assessable 0
Gado-not assessable, Pro-not confident 0
Gado-not assessable, Pro-confident 1
Gado-not assessable, Pro-not assessable 0
8.Secondary Outcome
Title Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE
Hide Description Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: participants
Gado-not confident, Pro-not confident 0
Gado-not confident, Pro-confident 1
Gado-not confident, Pro-not assessable 0
Gado-confident, Pro-not confident 0
Gado-confident, Pro-confident 150
Gado-confident, Pro-not assessable 0
Gado-not assessable, Pro-not confident 0
Gado-not assessable, Pro-confident 0
Gado-not assessable, Pro-not assessable 0
9.Secondary Outcome
Title Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Hide Description Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: participants
Gado-not confident, Pro-not confident 1
Gado-not confident, Pro-confident 0
Gado-not confident, Pro-not assessable 0
Gado-confident, Pro-not confident 0
Gado-confident, Pro-confident 149
Gado-confident, Pro-not assessable 0
Gado-not assessable, Pro-not confident 0
Gado-not assessable, Pro-confident 1
Gado-not assessable, Pro-not assessable 0
10.Secondary Outcome
Title Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Hide Description Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
Arm/Group Title Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 65 62
Measure Type: Number
Unit of Measure: participants
Gadobutrol was better than ProHance 26 22
ProHance was better than gadobutrol 15 10
Both image sets were comparable 24 30
11.Secondary Outcome
Title Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Hide Description Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
Arm/Group Title Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 88 88
Measure Type: Number
Unit of Measure: participants
Gadobutrol was better than ProHance 9 24
ProHance was better than gadobutrol 21 5
Both image sets were comparable 58 59
12.Secondary Outcome
Title Number of Participants With Reasons for Performance in SRS Planning by TPE
Hide Description Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
Arm/Group Title Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 65 62
Measure Type: Number
Unit of Measure: participants
Gadobutrol was better: newly detected lesions 2 5
Gadobutrol was better: lesion size exceeds limit 1 0
Gadobutrol better: newly treatable lesions 5 3
Gadobutrol was better: extended radiation area 8 5
Gadobutrol was better: clarified radiation area 15 11
ProHance was better: newly detected lesions 4 1
ProHance was better: lesion size exceeds the limit 1 0
ProHance was better: newly treatable lesions 4 2
ProHance was better: extended radiation area 3 5
ProHance was better: clarified radiation area 8 3
13.Secondary Outcome
Title Number of Participants With Reasons for Performance in SRS Planning by Investigator
Hide Description Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure
Arm/Group Title Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw
Hide Arm/Group Description:
Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
Overall Number of Participants Analyzed 88 88
Measure Type: Number
Unit of Measure: participants
Gadobutrol better: newly treatable lesions 2 8
Gadobutrol was better: extended radiation area 0 1
Gadobutrol was better: clarified radiation area 6 17
Gadobutrol was better: other 1 1
ProHance was better: newly treatable lesions 11 3
ProHance was better: extended radiation area 1 0
ProHance was better: clarified radiation area 8 2
ProHance was better: other 3 0
14.Secondary Outcome
Title Lesion Size Evaluated by Independent Radiologist
Hide Description Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 151 151 151
Mean (Standard Deviation)
Unit of Measure: mm
8.79  (8.06) 9.07  (8.19) 8.83  (8.02)
15.Secondary Outcome
Title Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
Hide Description CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 151 151 151
Mean (Standard Deviation)
Unit of Measure: CNR
36.74  (47.82) 60.09  (67.40) 53.01  (56.20)
16.Secondary Outcome
Title Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
Hide Description ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.
Time Frame one day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.
Arm/Group Title Gadobutrol 0.1 mmol/kg bw Gadobutrol 0.2 mmol/kg bw Gadoteridol (ProHance) 0.2mmol/kg bw
Hide Arm/Group Description:
Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
Overall Number of Participants Analyzed 151 151 151
Measure Type: Number
Unit of Measure: ICC
0.963 0.955 0.949
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadobutrol Period ProHance Period
Hide Arm/Group Description Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
All-Cause Mortality
Gadobutrol Period ProHance Period
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gadobutrol Period ProHance Period
Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)   2/162 (1.23%) 
General disorders     
General physical health deterioration * 1  0/161 (0.00%)  1/162 (0.62%) 
Hepatobiliary disorders     
Bile duct stone * 1  0/161 (0.00%)  1/162 (0.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Gadobutrol Period ProHance Period
Affected / at Risk (%) Affected / at Risk (%)
Total   2/161 (1.24%)   9/162 (5.56%) 
Gastrointestinal disorders     
Nausea * 1  0/161 (0.00%)  2/162 (1.23%) 
Vomiting * 1  1/161 (0.62%)  2/162 (1.23%) 
Investigations     
Glucose urine present * 1  0/161 (0.00%)  2/162 (1.23%) 
Nervous system disorders     
Headache * 1  0/161 (0.00%)  2/162 (1.23%) 
Skin and subcutaneous tissue disorders     
Rash * 1  1/161 (0.62%)  2/162 (1.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00522951     History of Changes
Other Study ID Numbers: 91569
310864 ( Other Identifier: Company internal )
First Submitted: August 29, 2007
First Posted: August 30, 2007
Results First Submitted: July 5, 2011
Results First Posted: August 3, 2011
Last Update Posted: August 28, 2017