Detection of Breast Lesions by Automatic Breast US

NCT03047122 | Unknown

• 1 other identifier: 0089-16ASMC
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasonography; Breast

Keywords

Breast; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 25 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women 25 years and up reffered to our centers for hend held us for various indications including screening and diagnostic setup

You may qualify if:

• 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).

You may not qualify if:

• Women under 25 years.

Sponsors & Collaborators

• Assuta Medical Center: lead

Study Sites (1)

Assuta Medical Centers

Tel Aviv, Israel

RECRUITING

Related Publications (11)

• Lander MR, Tabar 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. No abstract available.

  PMID: 22035673 BACKGROUND

• 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. Epub 2009 Sep 2.

  PMID: 19727744 BACKGROUND

• 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.

  PMID: 25615743 BACKGROUND

• 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.

  BACKGROUND

• 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. Epub 2008 Aug 14.

  PMID: 18704878 BACKGROUND

• 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. Epub 2010 Dec 30.

  PMID: 21191745 BACKGROUND

• 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. Epub 2014 Mar 28.

  PMID: 24682405 BACKGROUND

• 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.

  PMID: 21498319 BACKGROUND

• 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. Epub 2013 Apr 17.

  PMID: 23601952 BACKGROUND

• 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. Epub 2011 May 31. German.

  PMID: 21630181 BACKGROUND

• ACR BI-RADS Atlas 5th Edition, Breast Imaging Reporting and Data System 2013

  BACKGROUND

Study Officials

• Yuliana Weinstein, MD

  Assuta Medical Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Guindy, MD

CONTACT

+972-50-8800102; micahlgu@assuta.co.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Imaging Services

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 8, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)