N/A
N=1,681
Ultrasound Elastography of Breast Lesions
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00716482 ↗Enrolled (actual)
1,681
Serious AEs
—
Results posted
Sep 2013
Primary outcome: Primary: 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 — 451; 283; 464; 280 participants — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- SuperSonic Imagine
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
451; 283; 464; 280; 510; 278 | <0.001 sig |
| SECONDARY Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature |
385; 176; 105; 5; 34; 45 | <0.001 sig |
| SECONDARY Intraobserver Reliability of Quantitative SWE Measurements |
0.94; 0.95; 0.95; 0.71; 0.84; 0.87 | — |
| SECONDARY Interobserver Agreement of B Mode Ultrasound and SWE Features |
0.58; 0.53; 0.38; 0.59; 0.40; 0.57 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00716482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.