Breast CancerNCT00535678
Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram
An observational study of Breast Cancer, run by GE Healthcare at 1 site in United States.
Trial summary
To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2009
- 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: Women referred for normal screening mammogram
Who may be able to join
- Women ≥18 years or older for screening mammography
- Able and willing to comply with study procedures, and have signed and dated the informed consent form
- The subject is surgically sterile or postmenopausal
Who cannot join
- Pregnant or trying to become pregnant
- Has signs or symptoms of breast cancer
- Has been previously included in this study
- Has breast implants
- Has a history of breast cancer and is in active treatment
- Has breasts too large to be adequately positioned for the DBT examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography
To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.
- Conditions
- Breast Cancer
- Keywords
- Mammography, mammogram, breast, Abnormal and normal breast tissue
- Medical subject headings
- Breast Neoplasms, Antisocial Personality Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJul 2009
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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amy Longcore, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535678
- Sponsor's protocol ID
- GE 190-001
- Status last verified
- Apr 2010
- First submitted
- 24 Sep 2007
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography
- ClinicalTrials.gov ID
- NCT00535678
- Acronym / sponsor ID
- GE 190-001
- Conditions
- Breast Cancer
- Keywords
- Mammography, mammogram, breast, Abnormal and normal breast tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Sep 2007 (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.
To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women referred for normal screening mammogram
Key inclusion criteria (3 listed)
- Women ≥18 years or older for screening mammography
- Able and willing to comply with study procedures, and have signed and dated the informed consent form
- The subject is surgically sterile or postmenopausal
Key exclusion criteria (6 listed)
- Pregnant or trying to become pregnant
- Has signs or symptoms of breast cancer
- Has been previously included in this study
- Has breast implants
- Has a history of breast cancer and is in active treatment
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
Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.
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 14 May 2010.
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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.
Amy Longcore study director
GE Healthcare
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 3 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 14 May 2010. 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 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?
Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.. 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 14 May 2010; AzTrials last refreshed its copy on 27 Oct 2026.