Trial Outcomes & Findings for Ultrasound Elastography of Breast Lesions (NCT NCT00716482)
NCT ID: NCT00716482
Last Updated: 2013-09-09
Results Overview
Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size. Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions. Based on 939 lesions.
Recruitment status
COMPLETED
Target enrollment
1681 participants
Primary outcome timeframe
2 years
Results posted on
2013-09-09
Participant Flow
Recruitment dates: October 23, 2008 - June 15, 2010 Hospitals and private medical clinics in 16 sites worldwide participated.
Participant milestones
| Measure |
Breast Lesion
B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
|---|---|
|
Overall Study
STARTED
|
1681
|
|
Overall Study
COMPLETED
|
1562
|
|
Overall Study
NOT COMPLETED
|
119
|
Reasons for withdrawal
| Measure |
Breast Lesion
B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Inadequate acquisition or analysis
|
50
|
|
Overall Study
no pathology obtained
|
10
|
|
Overall Study
technical/machine error
|
28
|
|
Overall Study
inclusion/exclusion criteria not met
|
25
|
Baseline Characteristics
Ultrasound Elastography of Breast Lesions
Baseline characteristics by cohort
| Measure |
Breast Lesion
n=1681 Participants
B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
|---|---|
|
Age Continuous
|
51.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1681 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
322 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
566 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
529 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
89 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
175 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Per protocol. Analysis includes 289 malignant and 650 benign masses. One lesion was analyzed per participant.
Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size. Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions. Based on 939 lesions.
Outcome measures
| Measure |
Specificity
n=650 Participants
Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Sensitivity
n=289 Participants
Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Not Homogeneous
The Elastography image of the lesion is inhomogeneous and has a "mottled" or "patchy" appearance throughout.
|
|---|---|---|---|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
lesion shape
|
451 participants
|
283 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
lesion homogeneity-conservative strategy
|
464 participants
|
280 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
lesion homogeneity-aggressive strategy
|
510 participants
|
278 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
maximum elasticity (Emax)-conservative strategy
|
427 participants
|
286 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
maximum elasticity (Emax)-aggressive strategy
|
503 participants
|
281 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
median mean elasticity (Emean)
|
407 participants
|
285 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
diameter ration (Edia)
|
333 participants
|
286 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
median elasticity ratio (Erat)
|
422 participants
|
284 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
color score of Emax (Ecol)-conservative strategy
|
457 participants
|
288 participants
|
—
|
|
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
color score of Emax (Ecol)-aggressive strategy
|
510 participants
|
285 participants
|
—
|
SECONDARY outcome
Timeframe: performed on the same day, within 2 years from study start datePopulation: Per protocol. One lesion was analyzed per participant.
614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.
Outcome measures
| Measure |
Specificity
n=391 Participants
Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Sensitivity
n=212 Participants
Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Not Homogeneous
n=155 Participants
The Elastography image of the lesion is inhomogeneous and has a "mottled" or "patchy" appearance throughout.
|
|---|---|---|---|
|
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
Some images similar
|
5 participants
|
34 participants
|
45 participants
|
|
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
Images very dissimilar
|
1 participants
|
2 participants
|
5 participants
|
|
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
All images very or reasonably similar
|
385 participants
|
176 participants
|
105 participants
|
SECONDARY outcome
Timeframe: performed on the same day, within 2 years from study start datePopulation: Per protocol. 758 masses (614 benign and 144 malignant)are analyzed. One lesion was analyzed per participant. 3 acquisitions per lesion were analyzed with the ICC method for 10 different parameters.
614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.
Outcome measures
| Measure |
Specificity
n=758 Participants
Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Sensitivity
Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Not Homogeneous
The Elastography image of the lesion is inhomogeneous and has a "mottled" or "patchy" appearance throughout.
|
|---|---|---|---|
|
Intraobserver Reliability of Quantitative SWE Measurements
Diameter
|
0.94 correlation coefficient
Interval 0.94 to 0.95
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
Area
|
0.95 correlation coefficient
Interval 0.94 to 0.95
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
Perimeter
|
0.95 correlation coefficient
Interval 0.94 to 0.95
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
E minimum mass
|
0.71 correlation coefficient
Interval 0.68 to 0.74
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
E maximum mass
|
0.84 correlation coefficient
Interval 0.82 to 0.86
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
E mean mass
|
0.87 correlation coefficient
Interval 0.85 to 0.88
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
E ratio (mass:fat)
|
0.77 correlation coefficient
Interval 0.74 to 0.79
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
E minumum fat
|
0.57 correlation coefficient
Interval 0.53 to 0.61
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
E maximum fat
|
0.62 correlation coefficient
Interval 0.58 to 0.65
|
—
|
—
|
|
Intraobserver Reliability of Quantitative SWE Measurements
E mean fat
|
0.71 correlation coefficient
Interval 0.68 to 0.74
|
—
|
—
|
SECONDARY outcome
Timeframe: performed on the same day, after study completionPopulation: Per protocol. One lesion was analyzed per participant. Two independent readers did a qualitative assessment of 7 image parameters (per lesion) using Kappa.
614 benign and 144 malignant breast masses.
Outcome measures
| Measure |
Specificity
n=758 Participants
Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Sensitivity
Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
|
Not Homogeneous
The Elastography image of the lesion is inhomogeneous and has a "mottled" or "patchy" appearance throughout.
|
|---|---|---|---|
|
Interobserver Agreement of B Mode Ultrasound and SWE Features
B-mode shape
|
0.58 kappa statistic
Interval 0.51 to 0.65
|
—
|
—
|
|
Interobserver Agreement of B Mode Ultrasound and SWE Features
B-mode orientation
|
0.53 kappa statistic
Interval 0.46 to 0.6
|
—
|
—
|
|
Interobserver Agreement of B Mode Ultrasound and SWE Features
B-mode margin
|
0.38 kappa statistic
Interval 0.32 to 0.45
|
—
|
—
|
|
Interobserver Agreement of B Mode Ultrasound and SWE Features
B-mode BI-RADS assessment
|
0.59 kappa statistic
Interval 0.53 to 0.66
|
—
|
—
|
|
Interobserver Agreement of B Mode Ultrasound and SWE Features
SWE shape
|
0.40 kappa statistic
Interval 0.33 to 0.47
|
—
|
—
|
|
Interobserver Agreement of B Mode Ultrasound and SWE Features
SWE homogeneity
|
0.57 kappa statistic
Interval 0.51 to 0.64
|
—
|
—
|
|
Interobserver Agreement of B Mode Ultrasound and SWE Features
SWE Emax
|
0.66 kappa statistic
Interval 0.59 to 0.73
|
—
|
—
|
Adverse Events
Breast Lesion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place