Brain Tumor
Conditions
Brief summary
Compare the efficacy of MultiHance and Magnevist
Detailed description
The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.
Interventions
DRUGMultihance
0.5 M at a single injection
DRUGArm 2 - Magnevist
0.5 M Magnevist at a single dose injection
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Was 18 years or older * Provided written informed consent * Scheduled for MRI * Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days
Exclusion criteria
* Pregnant or lactating females * Allergy to one or more of the ingredients in the products or hypersensitivity to any metals * Congestive heart failure, class IV * Previous stroke in the past year * Received another contrast agent within 24 hours pre and post each exam * Investigational product * Contraindications to MRI * Severe claustrophobia * Surgery with 3 weeks prior * Steroid therapy or radiosurgery between two exams
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Diagnostic Preference Between the Two Exams | Postdose Images for MultiHance Exam and for Magnevist Exam Compared | Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Contrast Enhancement Between the Two Exams | Postdose Images for MultiHance Exam and for Magnevist Exam Compared | Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. |
| Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 | Predose and immediately postdose | Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed. |
| Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 | Predose and immediately postdose | Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed. |
| Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Predose and immediately postdose | Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed. |
| Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 | Predose and immediately postdose | Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed. |
| Lesion Border Delineation | Postdose Images for MultiHance Exam and for Magnevist Exam Compared | Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. |
| Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 | Predose and immediately postdose | Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed. |
| Percentage of Lesion Contrast Enhancement (LCE) - Reader 1 | Postdose | Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\] |
| Percentage of Contrast Enhancement of the Lesion - Reader 2 | Postdose | Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\] |
| Percentage of Contrast Enhancement of the Lesion - Reader 3 | Postdose | Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\] |
| Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 | Predose and immediately postdose | Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed. |
Countries
United States
Participant flow
Recruitment details
A total of 47 patients were recruited from March 2007 through February 2008 at 8 clinical trial sites. from Feb/18/2008 to Feb/22/2008, an off-site assessment of the images was performed by 3 board-certified radiologists who were blinded to which contrast agent was used, any patient's clinical information & any results from other imaging studies.
Pre-assignment details
47 patients enrolled (signed informed consent); 46 were randomized and dosed.
Participants by arm
| Arm | Count |
|---|---|
| MultiHance, Then Magnevist 0.1 mmol/kg injection of each product | 23 |
| Magnevist, Then MultiHance 0.1 mmol/kg injection of each product | 23 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patients did not complete both exams | 2 | 3 |
Baseline characteristics
| Characteristic | Magnevist, Then MultiHance | Total | MultiHance, Then Magnevist |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 7 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 39 Participants | 19 Participants |
| Age, Continuous | 48.08 years STANDARD_DEVIATION 16.064 | 49.43 years STANDARD_DEVIATION 15.667 | 50.79 years STANDARD_DEVIATION 15.497 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 42 Participants | 23 Participants |
| Region of Enrollment United States | 23 participants | 46 participants | 23 participants |
| Sex: Female, Male Female | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 43 | 1 / 44 |
| serious Total, serious adverse events | 0 / 43 | 0 / 44 |
Outcome results
Primary
Global Diagnostic Preference Between the Two Exams
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Population: Include all intention-to-treat (ITT) population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 | Global Diagnostic Preference Between the Two Exams | Contrast Agents Equal | 19 Contrast-enhanced Images |
| Reader 1 | Global Diagnostic Preference Between the Two Exams | MultiHance Preferred | 22 Contrast-enhanced Images |
| Reader 1 | Global Diagnostic Preference Between the Two Exams | Magnevist Preferred | 0 Contrast-enhanced Images |
| Reader 2 | Global Diagnostic Preference Between the Two Exams | Contrast Agents Equal | 19 Contrast-enhanced Images |
| Reader 2 | Global Diagnostic Preference Between the Two Exams | MultiHance Preferred | 21 Contrast-enhanced Images |
| Reader 2 | Global Diagnostic Preference Between the Two Exams | Magnevist Preferred | 1 Contrast-enhanced Images |
| Reader 3 | Global Diagnostic Preference Between the Two Exams | MultiHance Preferred | 27 Contrast-enhanced Images |
| Reader 3 | Global Diagnostic Preference Between the Two Exams | Magnevist Preferred | 0 Contrast-enhanced Images |
| Reader 3 | Global Diagnostic Preference Between the Two Exams | Contrast Agents Equal | 14 Contrast-enhanced Images |
p-value: <0.0001wilcoxon signed-rank test
p-value: <0.0001wilcoxon signed-rank test
p-value: <0.0001wilcoxon signed-rank test
Secondary
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 | Predose | -18.81 [ratio] | Standard Deviation 19.22 |
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 | Postdose | 60.76 [ratio] | Standard Deviation 66.88 |
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 | Change from Baseline | 79.56 [ratio] | Standard Deviation 71.57 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 | Predose | -11.70 [ratio] | Standard Deviation 20.85 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 | Postdose | 26.87 [ratio] | Standard Deviation 28.36 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1 | Change from Baseline | 38.57 [ratio] | Standard Deviation 33.7 |
p-value: 0.006295% CI: [20.72, 61.26]t-test, 2 sided
Secondary
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 | Change from Baseline | 84.26 [ratio] | Standard Deviation 63.43 |
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 | Predose | -18.30 [ratio] | Standard Deviation 19.11 |
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 | Postdose | 65.96 [ratio] | Standard Deviation 54.75 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 | Postdose | 38.94 [ratio] | Standard Deviation 40.41 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 | Change from Baseline | 53.31 [ratio] | Standard Deviation 52.46 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2 | Predose | -14.38 [ratio] | Standard Deviation 18.92 |
p-value: 0.002795% CI: [16.57, 45.33]t-test, 2 sided
Secondary
Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3
Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 | Postdose | 62.10 [ratio] | Standard Deviation 42.92 |
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 | Change from Baseline | 73.84 [ratio] | Standard Deviation 47.6 |
| Reader 1 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 | Predose | -11.75 [ratio] | Standard Deviation 17.7 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 | Postdose | 42.34 [ratio] | Standard Deviation 33.49 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 | Predose | -6.47 [ratio] | Standard Deviation 17.2 |
| Reader 2 | Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3 | Change from Baseline | 48.81 [ratio] | Standard Deviation 37.51 |
p-value: 0.0295% CI: [12.41, 37.67]t-test, 2 sided
Secondary
Lesion Border Delineation
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred.
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Population: Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 | Lesion Border Delineation | Magnevist Preferred | 0 Contrast-enhanced Images |
| Reader 1 | Lesion Border Delineation | MultiHance Preferred | 14 Contrast-enhanced Images |
| Reader 1 | Lesion Border Delineation | Contrast Agents Equal | 27 Contrast-enhanced Images |
| Reader 2 | Lesion Border Delineation | Contrast Agents Equal | 30 Contrast-enhanced Images |
| Reader 2 | Lesion Border Delineation | Magnevist Preferred | 0 Contrast-enhanced Images |
| Reader 2 | Lesion Border Delineation | MultiHance Preferred | 11 Contrast-enhanced Images |
| Reader 3 | Lesion Border Delineation | MultiHance Preferred | 13 Contrast-enhanced Images |
| Reader 3 | Lesion Border Delineation | Magnevist Preferred | 0 Contrast-enhanced Images |
| Reader 3 | Lesion Border Delineation | Contrast Agents Equal | 28 Contrast-enhanced Images |
p-value: 0.0001wilcoxon signed-rank test
p-value: 0.001wilcoxon signed-rank test
p-value: 0.0002wilcoxon signed-rank test
Secondary
Lesion Contrast Enhancement Between the Two Exams
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred.
Time frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Population: Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 | Lesion Contrast Enhancement Between the Two Exams | MultiHance Preferred | 22 Contrast-enhanced Images |
| Reader 1 | Lesion Contrast Enhancement Between the Two Exams | Magnevist Preferred | 0 Contrast-enhanced Images |
| Reader 1 | Lesion Contrast Enhancement Between the Two Exams | Contrast Agents Equal | 19 Contrast-enhanced Images |
| Reader 2 | Lesion Contrast Enhancement Between the Two Exams | Contrast Agents Equal | 20 Contrast-enhanced Images |
| Reader 2 | Lesion Contrast Enhancement Between the Two Exams | Magnevist Preferred | 1 Contrast-enhanced Images |
| Reader 2 | Lesion Contrast Enhancement Between the Two Exams | MultiHance Preferred | 20 Contrast-enhanced Images |
| Reader 3 | Lesion Contrast Enhancement Between the Two Exams | Magnevist Preferred | 1 Contrast-enhanced Images |
| Reader 3 | Lesion Contrast Enhancement Between the Two Exams | MultiHance Preferred | 22 Contrast-enhanced Images |
| Reader 3 | Lesion Contrast Enhancement Between the Two Exams | Contrast Agents Equal | 18 Contrast-enhanced Images |
p-value: <0.0001wilcoxon signed-rank test
p-value: <0.0001wilcoxon signed-rank test
p-value: <0.0001wilcoxon signed-rank test
Secondary
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 | Postdose | 1.50 [ratio] | Standard Deviation 0.3 |
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 | Predose | 0.82 [ratio] | Standard Deviation 0.17 |
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 | Change from Baseline | 0.68 [ratio] | Standard Deviation 0.33 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 | Predose | 0.85 [ratio] | Standard Deviation 0.19 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 | Postdose | 1.31 [ratio] | Standard Deviation 0.21 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1 | Change from Baseline | 0.46 [ratio] | Standard Deviation 0.24 |
p-value: <0.000195% CI: [0.14, 0.3]t-test, 2 sided
Secondary
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 | Predose | 0.82 [ratio] | Standard Deviation 0.18 |
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 | Postdose | 1.61 [ratio] | Standard Deviation 0.28 |
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 | Change from Baseline | 0.79 [ratio] | Standard Deviation 0.36 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 | Predose | 0.87 [ratio] | Standard Deviation 0.17 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 | Postdose | 1.36 [ratio] | Standard Deviation 0.22 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2 | Change from Baseline | 0.49 [ratio] | Standard Deviation 0.27 |
p-value: <0.000195% CI: [0.22, 0.38]t-test, 2 sided
Secondary
Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3
Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time frame: Predose and immediately postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Change from Baseline | 0.81 [ratio] | Standard Deviation 0.41 |
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Predose | 0.86 [ratio] | Standard Deviation 0.17 |
| Reader 1 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Postdose | 1.67 [ratio] | Standard Deviation 0.36 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Change from Baseline | 0.55 [ratio] | Standard Deviation 0.31 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Predose | 0.91 [ratio] | Standard Deviation 0.17 |
| Reader 2 | Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3 | Postdose | 1.46 [ratio] | Standard Deviation 0.26 |
p-value: <0.000195% CI: [0.18, 0.33]t-test, 2 sided
Secondary
Percentage of Contrast Enhancement of the Lesion - Reader 2
Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Time frame: Postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reader 1 | Percentage of Contrast Enhancement of the Lesion - Reader 2 | 106.42 [percent] | Standard Deviation 84.97 |
| Reader 2 | Percentage of Contrast Enhancement of the Lesion - Reader 2 | 72.81 [percent] | Standard Deviation 65.7 |
p-value: 0.000895% CI: [16.75, 50.47]t-test, 2 sided
Secondary
Percentage of Contrast Enhancement of the Lesion - Reader 3
Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Time frame: Postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reader 1 | Percentage of Contrast Enhancement of the Lesion - Reader 3 | 101.85 [percent] | Standard Deviation 96.89 |
| Reader 2 | Percentage of Contrast Enhancement of the Lesion - Reader 3 | 68.13 [percent] | Standard Deviation 60.91 |
p-value: 0.002695% CI: [14.63, 52.81]t-test, 2 sided
Secondary
Percentage of Lesion Contrast Enhancement (LCE) - Reader 1
Quantitative parameter derived from signal intensity (SI) measurements. LCE (\[SI of lesion (postdose)-SI of lesion (predose)\]/Standard SI of lesion (predose)\]
Time frame: Postdose
Population: Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reader 1 | Percentage of Lesion Contrast Enhancement (LCE) - Reader 1 | 100.15 [percent] | Standard Deviation 74.92 |
| Reader 2 | Percentage of Lesion Contrast Enhancement (LCE) - Reader 1 | 67.38 [percent] | Standard Deviation 52.18 |
p-value: 0.001995% CI: [14.28, 51.25]t-test, 2 sided