Breast NeoplasmsBE3NCT02226081
ShearWave™ Elastography of Breast Lesions in Chinese Patients
An observational study of Breast Neoplasms, run by SuperSonic Imagine at 22 sites in China.
Trial summary
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 2,273 participants
- Where
- 22 sitesChina
- Study dates
- Jun 2014to Jun 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Chinese women (age of majority) who have been referred to a hospital or clinical for a breast ultrasound evaluation.
Who may be able to join
- female
- 18 years of age or older
- known breast lesion that has not been managed or treated
- referred for a breast ultrasound because of a breast mass found on at least one of the following examinations:
- physical palpation
- mammography
- ultrasound exam
- MRI
Who cannot join
- Women who are unwilling or unable to provide informed consent
- Women with breast implants
- Women who are pregnant or breastfeeding
- Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6
- Women with previous ipsilateral breast surgery
- Women with no visible breast mass on ultrasound examination
Show all 9Show fewer
- Women with axillary metastatic lymph nodes only
- Women with foreign body in the breast
- Women who are not Chinese nationality
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
1st Affiliated Hospital of PLAGH (304)
Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing
People's Liberation Army General Hospital (301)
Beijing
Affiliated Hospital of Binzhou Medical University
Binzhou
Sichuan Provincial People's Hospital
Chengdu
West China Hospital, Sichuan University
Chengdu
Fujian Provincial Cancer Hospital
Fuzhou
Guangdong Provincial Traditional Chinese Medical Hospital
Guangzhou
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou
Sun-Yat Sen University Cancer Center
Guangzhou
1st Affiliated Hospital of Harbin University
Harbin
Hefei 2nd People's Hospital
Hefei
Jiangsu Provincial Hospital
Nanjing
Yinzhou People's Hospital
Ningbo
Fudan University Cancer Center
Shanghai
1st Affiliated Hospital of China Medical University
Shenyang
4th Affiliated Hospital of China Medical University
Shenyang
Shengjing Hospital of China Medical University
Shenyang
General Hospital of TISCO
Taiyuan
Shanxi Dayi Hospital
Taiyuan
1st Affiliated Hospital of Xi'an Jiaotong University
Xi'an
1st Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.
Read the detailed description
Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.
- Conditions
- Breast Neoplasms
- Keywords
- breast lesion, ultrasound, BI-RADS, women, malignancy
- Medical subject headings
- Breast Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in specificity of breast ultrasound imaging when considering stiffness measurements
Measured: Within 18 months of the study start date
Secondary outcomes (2)
Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements
Measured: Within 18 months of the study start date
Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements
Measured: within 18 months of the study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 2,273 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuperSonic Imagine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cai Chang, Principal investigator, Fudan UniversityAnhua Li, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226081
- Sponsor's protocol ID
- BE3
- Other IDs
- ChiCTR-DDT-14004785
- Acronym
- BE3
- Status last verified
- Dec 2018
- First submitted
- 25 Aug 2014
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin X, Chang C, Wu C, Chen Q, Peng Y, Luo B, Tang L, Li J, Zheng J, Zhou R, Cui G, Li A, Wang X, Qian L, Zhang J, Wen C, Gay J, Zhang H, Li A, Chen Y. Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial. Cancer Manag Res. 2018 Oct 11;10:4447-4458. doi: 10.2147/CMAR.S174690. eCollection 2018.
PubMed 30349377
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients
- ClinicalTrials.gov ID
- NCT02226081
- Acronym / sponsor ID
- BE3 / BE3
- Conditions
- Breast Neoplasms
- Keywords
- breast lesion, ultrasound, BI-RADS, women, malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,273 participants (actual)
- Lead sponsor
- SuperSonic ImagineIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Aug 2014 (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.
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.
Detailed description
Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese women (age of majority) who have been referred to a hospital or clinical for a breast ultrasound evaluation.
Key inclusion criteria (8 listed)
- female
- 18 years of age or older
- known breast lesion that has not been managed or treated
- referred for a breast ultrasound because of a breast mass found on at least one of the following examinations:
Key exclusion criteria (9 listed)
- Women who are unwilling or unable to provide informed consent
- Women with breast implants
- Women who are pregnant or breastfeeding
- Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6
- Women with previous ipsilateral breast surgery
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
Increase in specificity of breast ultrasound imaging when considering stiffness measurements
Time frame: Within 18 months of the study start date
2 secondary outcomes
Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements
Time frame: Within 18 months of the study start date
Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements
Time frame: within 18 months of the study start date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Results publication: PubMed 30349377Lin X, Chang C, Wu C, Chen Q, Peng Y, Luo B, Tang L, Li J, Zheng J, Zhou R, Cui G, Li A, Wang X, Qian L, Zhang J, Wen C, Gay J, Zhang H, Li A, Chen Y. Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial. Cancer Manag Res. 2018 Oct 11;10:4447-4458. doi: 10.2147/CMAR.S174690. eCollection 2018.
- Full-length article in Cancer Management and Research journalLink provided by the sponsor.
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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.
Cai Chang principal investigator
Fudan University
Anhua Li principal investigator
Sun Yat-sen University
22 sites in 1 country: 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 22 sites in China.
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 8 inclusion and 9 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 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase in specificity of breast ultrasound imaging when considering stiffness measurements (time frame: Within 18 months of the study start date). 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 NCT02226081, which also lists 1 linked publication.
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 20 Dec 2018.