Ultrasound Elastography of Breast Lesions (BE1)
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|ClinicalTrials.gov Identifier: NCT00716482|
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : September 9, 2013
Last Update Posted : September 9, 2013
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1681 participants|
|Official Title:||Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
- 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 ]
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 ]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 ]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 ]614 benign and 144 malignant breast masses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospitals NHS Trust|