Breast NeoplasmsBE1NCT00716482
Ultrasound Elastography of Breast Lesions
An observational study of Breast Neoplasms, run by SuperSonic Imagine at 16 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 1,681 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Jul 2008to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Population will consist of women who have been referred to a public or private hospital or clinic for a breast ultrasound evaluation. The sites are located various cities throughout the United States and Europe.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States6 sites
Boston Medical Center, Radiology
Boston, Massachusetts, 02118
Northwestern Memorial Hospital, Dept. of Radiology
Chicago, Illinois, 60611
Sally Jobe Breast Center
Denver, Colorado, 80206
University of Southern California - LAC+USC Medical Center, OPD Rm 3P61
Los Angeles, California, 90033
Yale Medical Center, Department of Diagnostic Radiology
New Haven, Connecticut, 06510
Thomas Jefferson Medical Center, Department of Radiology
Philadelphia, Pennsylvania, 19107
France4 sites
Hôpital Privé Jean Mermoz
Lyon
University Hospital La Timone
Marseille
Centre Antoine Lacassagne
Nice
Institut Curie
Paris
Germany4 sites
University Hospital, Frauenklinik
Greifswald
University Hospital Schleswig-Holstein
Kiel
Marienhospital, Klinik für Radiologie
Osnabrück
German Diagnostic Clinic
Wiesbaden
About this study
Official title: Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions
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
- Breast Neoplasms
- Keywords
- breast, lesion, ultrasound, BI-RADS, malignancy, women
- Medical subject headings
- Breast Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 2 years
Secondary outcomes (3)
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
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.
Measured: performed on the same day, within 2 years from study start date
Intraobserver Reliability of Quantitative SWE Measurements
614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.
Measured: performed on the same day, within 2 years from study start date
Interobserver Agreement of B Mode Ultrasound and SWE Features
614 benign and 144 malignant breast masses.
Measured: performed on the same day, after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Cross-sectional
- Enrolment
- 1,681 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuperSonic Imagine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David O Cosgrove, MD, Principal investigator, Hammersmith Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716482
- Sponsor's protocol ID
- A00152-53
- Acronym
- BE1
- Status last verified
- Sep 2013
- First submitted
- 14 Jul 2008
- Last updated
- 9 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cosgrove 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.
PubMed 22210408Berg 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.
PubMed 22282182
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions
- ClinicalTrials.gov ID
- NCT00716482
- Acronym / sponsor ID
- BE1 / A00152-53
- Conditions
- Breast Neoplasms
- Keywords
- breast, lesion, ultrasound, BI-RADS, malignancy, women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,681 participants (actual)
- Lead sponsor
- SuperSonic ImagineIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 9 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will consist of women who have been referred to a public or private hospital or clinic for a breast ultrasound evaluation. The sites are located various cities throughout the United States and Europe.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
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
Time frame: 2 years
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.
3 secondary outcomes
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
Time frame: performed on the same day, within 2 years from study start date
Intraobserver Reliability of Quantitative SWE Measurements
Time frame: performed on the same day, within 2 years from study start date
Interobserver Agreement of B Mode Ultrasound and SWE Features
Time frame: performed on the same day, after study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22210408Cosgrove 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.
- Results publication: PubMed 22282182Berg 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.
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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.
David O Cosgrove, MD principal investigator
Hammersmith Hospitals NHS Trust
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by SuperSonic Imagine at 16 sites in 5 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, France, Germany, Italy, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). 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 NCT00716482, which also lists 2 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 9 Sep 2013.