Ultrasonography Clinical Trial
Official title:
Detection of Breast Lesions by Automatic Breast US (Comparison to Current Hand Held US and Pathological Findings When Exist).
Mammography is considered the standard imaging method for breast cancer screening, and is
known to result in reduced mortality from breast cancer. However, the diagnostic yield of
mammography depends particularly on breast tissue density, with sensitivity as low as 30-48%
in dense-breast women. Ultrasound is an attractive adjunct imaging method to mammography as
it is widely accessible, relatively inexpensive and well-tolerated by patients. The addition
of hand-held ultrasound to mammography has been demonstrated to significantly increase
breast cancer detection in women with dense breasts. It is however dependent on the
expertise and skill of the operator.
In recent years, the FDA has approved the use of the automated breast ultrasound (ABUS) for
use in screening of women with dense breast. Unlike handheld ultrasound, the ABUS is
relatively simple to use, necessitating less technical training, and results in higher
reproducibility.
The research aim is to evaluation of automated breast ultrasound (ABUS) regarding the
detection and classification of breast lesions, compared to hand-held ultrasound, according
to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS)
classification. The investigator will also evaluate parameters regarding patients' comfort,
workflow, and duration of image interpretation.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 99 Years |
Eligibility |
Inclusion Criteria: Women referred to hand-held screening ultrasound examination (BI-RADS=1/2). Women scheduled to undergo ultrasound-guided needle biopsy due to suspicious breast mass detected during hand-held ultrasound (BI-RADS>2). Exclusion Criteria: Women under 25 years. |
Country | Name | City | State |
---|---|---|---|
Israel | Assuta Medical Centers | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Assuta Medical Center |
Israel,
ACR BI-RADS Atlas 5th Edition, Breast Imaging Reporting and Data System 2013
Brem RF, Lenihan MJ, Lieberman J, Torrente J. Screening breast ultrasound: past, present, and future. AJR Am J Roentgenol. 2015 Feb;204(2):234-40. doi: 10.2214/AJR.13.12072. Review. — View Citation
Chang JM, Moon WK, Cho N, Park JS, Kim SJ. Breast cancers initially detected by hand-held ultrasound: detection performance of radiologists using automated breast ultrasound data. Acta Radiol. 2011 Feb 1;52(1):8-14. doi: 10.1258/ar.2010.100179. — View Citation
Drukker K, Horsch KJ, Pesce LL, Giger ML. Interreader scoring variability in an observer study using dual-modality imaging for breast cancer detection in women with dense breasts. Acad Radiol. 2013 Jul;20(7):847-53. doi: 10.1016/j.acra.2013.02.007. — View Citation
Kelly KM, Dean J, Comulada WS, Lee SJ. Breast cancer detection using automated whole breast ultrasound and mammography in radiographically dense breasts. Eur Radiol. 2010 Mar;20(3):734-42. doi: 10.1007/s00330-009-1588-y. — View Citation
Lander MR, Tabár L. Automated 3-D breast ultrasound as a promising adjunctive screening tool for examining dense breast tissue. Semin Roentgenol. 2011 Oct;46(4):302-8. doi: 10.1053/j.ro.2011.06.003. Review. — View Citation
Prosch H, Halbwachs C, Strobl C, Reisner LM, Hondl M, Weber M, Mostbeck GH. [Automated breast ultrasound vs. handheld ultrasound: BI-RADS classification, duration of the examination and patient comfort]. Ultraschall Med. 2011 Oct;32(5):504-10. doi: 10.1055/s-0031-1273414. German. — View Citation
Skaane P, Gullien R, Eben EB, Sandhaug M, Schulz-Wendtland R, Stoeblen F. Interpretation of automated breast ultrasound (ABUS) with and without knowledge of mammography: a reader performance study. Acta Radiol. 2015 Apr;56(4):404-12. doi: 10.1177/0284185114528835. — View Citation
Tozaki M, Fukuma E. Accuracy of determining preoperative cancer extent measured by automated breast ultrasonography. Jpn J Radiol. 2010 Dec;28(10):771-3. doi: 10.1007/s11604-010-0499-9. — View Citation
Wenkel E, Heckmann M, Heinrich M, Schwab SA, Uder M, Schulz-Wendtland R, Bautz WA, Janka R. Automated breast ultrasound: lesion detection and BI-RADS classification--a pilot study. Rofo. 2008 Sep;180(9):804-8. doi: 10.1055/s-2008-1027563. — View Citation
Zintsmaster BS, Morrison J, Sharman S, Shah BA. Differences in pain perceptions between automated breast ultrasound and digital screening mammography. J Diag Med Sonography 2013;29(2):62-65.
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ability to identify all US breast findings correctly. | The investigators will compare all lesions detected by abus and hand held US to pathology when present . | 6 month |
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