Clinical trial · Observational
Ultrasound Elastography of Breast Lesions
Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions
NCT00716482CI-TRIAL-00012033BE1completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (3)
- measure
- Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
- timeFrame
- performed on the same day, within 2 years from study start date
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI. * female * age 21 or older * provide informed consent Exclusion Criteria: * Women who are unwilling or unable to provide informed consent * Women with breast implants * Women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface) * Women who are pregnant or breastfeeding * Women who are undergoing chemotherapy or radiotherapy for any cancer * Women with previous breast conserving surgery on the breast of interest Note: Previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.
References
Publications (2)
- RESULTCosgrove DO, Berg WA, Dore CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31. PMID 22210408
- RESULTBerg WA, Cosgrove DO, Dore CJ, Schafer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640. PMID 22282182