Ultrasound Elastography of Breast Lesions (BE1)
Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions|
- 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
- Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature [ Time Frame: performed on the same day, within 2 years from study start date ] [ Designated as safety issue: No ]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.
- Intraobserver Reliability of Quantitative SWE Measurements [ Time Frame: performed on the same day, within 2 years from study start date ] [ Designated as safety issue: No ]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.
- Interobserver Agreement of B Mode Ultrasound and SWE Features [ Time Frame: performed on the same day, after study completion ] [ Designated as safety issue: No ]614 benign and 144 malignant breast masses.
|Study Start Date:||July 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716482
|United States, California|
|University of Southern California - LAC+USC Medical Center, OPD Rm 3P61|
|Los Angeles, California, United States, 90033|
|United States, Colorado|
|Sally Jobe Breast Center|
|Denver, Colorado, United States, 80206|
|United States, Connecticut|
|Yale Medical Center, Department of Diagnostic Radiology|
|New Haven, Connecticut, United States, 06510|
|United States, Illinois|
|Northwestern Memorial Hospital, Dept. of Radiology|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Boston Medical Center, Radiology|
|Boston, Massachusetts, United States, 02118|
|United States, Pennsylvania|
|Thomas Jefferson Medical Center, Department of Radiology|
|Philadelphia, Pennsylvania, United States, 19107|
|Hôpital Privé Jean Mermoz|
|University Hospital La Timone|
|Centre Antoine Lacassagne|
|University Hospital, Frauenklinik|
|University Hospital Schleswig-Holstein|
|Marienhospital, Klinik für Radiologie|
|German Diagnostic Clinic|
|Ospedale Civile di Gorizia|
|Charings Cross Hospital|
|London, United Kingdom|
|Principal Investigator:||David O Cosgrove, MD||Hammersmith Hospital, London, UK|