UltrasonographyNCT03047122
Detection of Breast Lesions by Automatic Breast US
An observational study of Ultrasonography and Breast, run by Assuta Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Breast
- How many people
- 1,200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women 25 years and up reffered to our centers for hend held us for various indications including screening and diagnostic setup
Who may be able to join
- 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).
Who cannot join
- Women under 25 years.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assuta Medical Centers
Tel Aviv
Yuliana Weinstein, MD, 972-52-4262514, yulianawe@assuta.co.il
Michal Guindy, MD, 972-50-8800102, michalgu@assuta.co.il
About this study
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.
Read the detailed description
ABUS produces a 3D volume acquisition using a 6-15 Mega Herz reverse curve transducer. Images are digitally reformatted on a dedicated workstation to produce axial, sagittal and coronal reformatted images. Unlike handheld ultrasound, the ABUS is relatively simple to use, necessitating less technical training, and results in higher reproducibility. Previous studies have shown that automated breast ultrasound is very well tolerated by patients can be useful in detection of solid and cystic lesions and in evaluating tumor extent preoperatively.
Automated breast ultrasound will be performed on the "Invenia ABUS" (Automated Breast Ultrasound System) designed for automated breast imaging by General Electric (GE) Healthcare. Images will be acquired using a 15 centimeter field-of-view reverse curve ultra-broadband transducer of 6-15 Mega Herz. Using mechanical compression assist, the transducer is placed on each breast and six volumes are acquired with six sweeps (right anterior-posterior, right lateral, right medial; left anterior-posterior, left lateral, left medial). Acquisition time expected 15 minutes per patient, approximately 30-40 second acquisition per volume.
ABUS examinations will be performed by the investigators institution's radiographers, with variable degrees of experience in performing hand-held breast ultrasound examinations (HHUS).
Reformatted images and volumes will be view on a designated workstation of 2 megapixel high resolution monitor, using customized hanging protocols, multi-slice 3D viewing and patented clinical algorithms. Interpretation of images will be done by our institution's breast imaging radiologists with more than 15 years of experience in performing and reading hand-held breast ultrasound studies.
Each breast will be assigned a final ABUS BI-RADS score according to the American College of Radiology classification ranging from 1 to 6. A discrepancy between the ABUS Breast Imaging-Reporting and Data System score and the hand-held ultrasound BI-RADS score (HHUS BI-RADS 1-2 \& ABUS BI-RADS >2, or HHUS BI-RADS >3 \& ABUS BI-RADS 1-2) will result in the referral of the woman to second-look hand-held ultrasound to determine the reason for the mismatch.
- Conditions
- Ultrasonography, Breast
- Keywords
- Breast, ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Guindy, Assuta Medical Center
- Investigators
- Yuliana Weinstein, MD, Principal investigator, Assuta Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047122
- Sponsor's protocol ID
- 0089-16ASMC
- Status last verified
- Mar 2017
- First submitted
- 7 Feb 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22035673Kelly 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.
PubMed 19727744Brem 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.
PubMed 25615743Zintsmaster 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.
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.
PubMed 18704878Tozaki 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.
PubMed 21191745Skaane 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.
PubMed 24682405Chang 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.
PubMed 21498319Drukker 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.
PubMed 23601952Prosch 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.
PubMed 21630181ACR BI-RADS Atlas 5th Edition, Breast Imaging Reporting and Data System 2013
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Breast Lesions by Automatic Breast US (Comparison to Current Hand Held US and Pathological Findings When Exist).
- ClinicalTrials.gov ID
- NCT03047122
- Acronym / sponsor ID
- 0089-16ASMC
- Conditions
- Ultrasonography, Breast
- Keywords
- Breast, ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ABUS produces a 3D volume acquisition using a 6-15 Mega Herz reverse curve transducer. Images are digitally reformatted on a dedicated workstation to produce axial, sagittal and coronal reformatted images. Unlike handheld ultrasound, the ABUS is relatively simple to use, necessitating less technical training, and results in higher reproducibility. Previous studies have shown that automated breast ultrasound is very well tolerated by patients can be useful in detection of solid and cystic lesions and in evaluating tumor extent preoperatively.
Automated breast ultrasound will be performed on the "Invenia ABUS" (Automated Breast Ultrasound System) designed for automated breast imaging by General Electric (GE) Healthcare. Images will be acquired using a 15 centimeter field-of-view reverse curve ultra-broadband transducer of 6-15 Mega Herz. Using mechanical compression assist, the transducer is placed on each breast and six volumes are acquired with six sweeps (right anterior-posterior, right lateral, right medial; left anterior-posterior, left lateral, left medial). Acquisition time expected 15 minutes per patient, approximately 30-40 second acquisition per volume.
ABUS examinations will be performed by the investigators institution's radiographers, with variable degrees of experience in performing hand-held breast ultrasound examinations (HHUS).
Reformatted images and volumes will be view on a designated workstation of 2 megapixel high resolution monitor, using customized hanging protocols, multi-slice 3D viewing and patented clinical algorithms. Interpretation of images will be done by our institution's breast imaging radiologists with more than 15 years of experience in performing and reading hand-held breast ultrasound studies.
Each breast will be assigned a final ABUS BI-RADS score according to the American College of Radiology classification ranging from 1 to 6. A discrepancy between the ABUS Breast Imaging-Reporting and Data System score and the hand-held ultrasound BI-RADS score (HHUS BI-RADS 1-2 \& ABUS BI-RADS >2, or HHUS BI-RADS >3 \& ABUS BI-RADS 1-2) will result in the referral of the woman to second-look hand-held ultrasound to determine the reason for the mismatch.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women 25 years and up reffered to our centers for hend held us for various indications including screening and diagnostic setup
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Women under 25 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ability to identify all US breast findings correctly.
Time frame: 6 month
The investigators will compare all lesions detected by abus and hand held US to pathology when present .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Background: PubMed 22035673Lander 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.
- Background: PubMed 19727744Kelly 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.
- Background: PubMed 25615743Brem 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.
- BackgroundZintsmaster 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: PubMed 18704878Wenkel 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.
- Background: PubMed 21191745Tozaki 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.
- Background: PubMed 24682405Skaane 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.
- Background: PubMed 21498319Chang 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.
- Background: PubMed 23601952Drukker 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.
- Background: PubMed 21630181Prosch 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.
- BackgroundACR BI-RADS Atlas 5th Edition, Breast Imaging Reporting and Data System 2013
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuliana Weinstein, MD principal investigator
Assuta Medical Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography and Breast, run by Assuta Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Guindy, MD (+972-50-8800102, micahlgu@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ability to identify all US breast findings correctly. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047122, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.