Breast CancerNCT01963624
Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
An observational study of Breast Cancer, run by Seoul National University Hospital at 10 sites in South Korea.
Trial summary
The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 1,241 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Nov 2013to Jan 2016
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population will consist of asymptomatic women who visit the hospital for breast screening. The sites are located in 4 cities of South Korea.
Who may be able to join
- Women aged 30 years or older screened with breast ultrasound without specific symptoms
- Women who underwent mammography within 3 months which showed no abnormality except for dense breast
- Women who had at least one breast mass of BI-RADS category 3 or higher.
Who cannot join
- Women with breast implants
- Women who are unwilling or unable to provide informed consent
- Lesions larger than 3 cm
- Lesions that are previously noted and followed-up in the same hospital
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Dongnam Inst. of Radiological and Medical Sciences
Busan
Gyeongsang National University Hospital
Jinju
CHA Bundang Medical Center, School of Medicine, CHA University
Seongnam-si
Ewha Womans University Mokdong Hospital
Seoul
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul
Hanyang University Medical Center
Seoul
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul
Seoul Metroplitan Government-Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital Healthcare System Gangnam Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.
Read the detailed description
- Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists.
- The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively.
- Reference standard: Biopsy or 1 year of follow-up examination.
- The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.
- Conditions
- Breast Cancer
- Being tested
- Ultrasonography
- Keywords
- Breast, Screening, Ultrasound, Elastography, Doppler ultrasonography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Also called Aixplorer system (SuperSonic Imagine, France), EUB-series/HV-ASCENDUS (Hitachi Medical, Japan)
Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.
| Study group | Role | What they receive |
|---|---|---|
| Breast masses detected with screening US | Those assessed with conventional B-mode US alone and those assessed with combined elastography and color doppler ultrasonography along with B-mode US. Receives: Device: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of breast screening with US
Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
Measured: 1 year after enrollment
Secondary outcomes (3)
Sensitivity
Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
Measured: 1 year after enrollment
Specificity
Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
Measured: 1 year after enrollment
Diagnostic accuracy
Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Kyung Moon, Seoul National University Hospital
- Investigators
- Woo Kyung Moon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963624
- Sponsor's protocol ID
- Elasto-Doppler Ultrasonography
- Status last verified
- Apr 2016
- First submitted
- 13 Oct 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
- ClinicalTrials.gov ID
- NCT01963624
- Acronym / sponsor ID
- Elasto-Doppler Ultrasonography
- Conditions
- Breast Cancer
- Keywords
- Breast, Screening, Ultrasound, Elastography, Doppler ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,241 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Oct 2013 (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.
The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.
Detailed description
- Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists.
- The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively.
- Reference standard: Biopsy or 1 year of follow-up examination.
- The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast masses detected with screening US | – | Device: UltrasonographyThose assessed with conventional B-mode US alone and those assessed with combined elastography and color doppler ultrasonography along with B-mode US. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population will consist of asymptomatic women who visit the hospital for breast screening. The sites are located in 4 cities of South Korea.
Key inclusion criteria (3 listed)
- Women aged 30 years or older screened with breast ultrasound without specific symptoms
- Women who underwent mammography within 3 months which showed no abnormality except for dense breast
- Women who had at least one breast mass of BI-RADS category 3 or higher.
Key exclusion criteria (4 listed)
- Women with breast implants
- Women who are unwilling or unable to provide informed consent
- Lesions larger than 3 cm
- Lesions that are previously noted and followed-up in the same hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyAlso: Aixplorer system (SuperSonic Imagine, France), EUB-series/HV-ASCENDUS (Hitachi Medical, Japan)Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US. | Device | Breast masses detected with screening US |
Primary outcome
Positive predictive value of breast screening with US
Time frame: 1 year after enrollment
Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
3 secondary outcomes
Sensitivity
Time frame: 1 year after enrollment
Specificity
Time frame: 1 year after enrollment
Diagnostic accuracy
Time frame: 1 year after enrollment
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 Apr 2016.
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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.
Woo Kyung Moon, M.D., Ph.D. principal investigator
Seoul National University Hospital
10 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 Cancer, run by Seoul National University Hospital at 10 sites in South Korea.
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 3 inclusion and 4 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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?
Positive predictive value of breast screening with US (time frame: 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2016.