Breast CancerNCT02042456
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
An observational study of Breast Cancer, run by GE Healthcare at 1 site in United States.
Trial summary
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Digital Breast Tomosynthesis, Automated Whole Breast Ultrasound and Full Field Digital Mammography
- Type of treatment
- Medical device
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be selected from the patients arriving at the clinic for yearly breast cancer screening exams
Who may be able to join
- Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
- Women aged ≥18 years at the time of enrollment;*
- Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
- At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
- AND Referred for screening mammography
Who cannot join
- Have been screened using any breast imaging technology in <12 months immediately prior to enrollment;
- Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
- Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
- Are currently pregnant as determined per standard clinical practice at the investigational site;
- Present with contraindications to any imaging examination required in the study protocol;
- Have breast implants; OR
- Are lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
- Conditions
- Breast Cancer
- Being tested
- Digital Breast Tomosynthesis, Automated Whole Breast Ultrasound, Full Field Digital Mammography
- Keywords
- breast cancer, dense breasts, mammography screening, Screening techniques, women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast TomosynthesisDevice
Also called GE SenoClaire DBT with V-Preview
digital breast tomosynthesis technology
Automated Whole Breast UltrasoundDevice
Also called Invenia ABUS
Automated Whole Breast Ultrasound
Full Field Digital MammographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit. Receives: Device: Digital Breast Tomosynthesis; Device: Automated Whole Breast Ultrasound; Device: Full Field Digital Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal interpretation rate
Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).
Measured: One Year
Secondary outcomes (5)
Sensitivity
Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Measured: One Year
Specificity
Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Measured: One Year
Cancer Rate
Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Measured: One Year
Positive Predictive Value
Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Measured: One Year
Negative Predictive Value
Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Change in study staff at the site, change in Sponsor direction
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 GE HealthcareThe 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
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042456
- Sponsor's protocol ID
- 124.03-2013-GES-0003
- Status last verified
- Oct 2015
- First submitted
- 20 Jan 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
- ClinicalTrials.gov ID
- NCT02042456
- Acronym / sponsor ID
- 124.03-2013-GES-0003
- Conditions
- Breast Cancer
- Keywords
- breast cancer, dense breasts, mammography screening, Screening techniques, women
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in study staff at the site, change in Sponsor direction
- Enrolment
- 124 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Jan 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.
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | Device: Digital Breast Tomosynthesis, Device: Automated Whole Breast Ultrasound, Device: Full Field Digital MammographySubjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from the patients arriving at the clinic for yearly breast cancer screening exams
Key inclusion criteria (5 listed)
- Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
- Women aged ≥18 years at the time of enrollment;*
- Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
- At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
- AND Referred for screening mammography
Key exclusion criteria (7 listed)
- Have been screened using any breast imaging technology in <12 months immediately prior to enrollment;
- Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
- Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
- Are currently pregnant as determined per standard clinical practice at the investigational site;
- Present with contraindications to any imaging examination required in the study protocol;
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 |
|---|---|---|
| Digital Breast TomosynthesisAlso: GE SenoClaire DBT with V-Previewdigital breast tomosynthesis technology | Device | Main Cohort |
| Automated Whole Breast UltrasoundAlso: Invenia ABUSAutomated Whole Breast Ultrasound | Device | Main Cohort |
| Full Field Digital Mammography | Device | Main Cohort |
Primary outcome
Abnormal interpretation rate
Time frame: One Year
Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).
5 secondary outcomes
Sensitivity
Time frame: One Year
Specificity
Time frame: One Year
Cancer Rate
Time frame: One Year
Positive Predictive Value
Time frame: One Year
Negative Predictive Value
Time frame: One Year
Results and safety
The study was stopped early (reason given: Change in study staff at the site, change in Sponsor direction). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer, run by GE Healthcare at 1 site in United States.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Oct 2015. 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 United States. 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 was stopped early (reason given: Change in study staff at the site, change in Sponsor direction). Results are not available in the source record.
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?
Abnormal interpretation rate (time frame: One Year). 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 Oct 2015.