Breast AbnormalitiesNCT01106911
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
A study testing tomosynthesis and screening mammography in people with Breast Abnormalities, run by University of Pittsburgh at 1 site in United States.
Trial summary
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Abnormalities
- What is being tested?
- tomosynthesis and screening mammography
- Type of treatment
- Medical device
- How many people
- 1,080 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2014
- Phase
- Interventional
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 34 and 56.
- Women presenting for their baseline screening mammography examination
Who cannot join
- Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
- Women who may be or are pregnant by self report
- Women older than 55 years of age or younger than 35.
- Women with known fatty breast tissue
- Males and children
- Women who are unable to understand or execute written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.
Read the detailed description
The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.
- Conditions
- Breast Abnormalities
- Being tested
- tomosynthesis and screening mammography
- Keywords
- digital breast tomosynthesis, baseline screening mammography, recall rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomosynthesis and screening mammographyDevice
Also called digital breast tomosynthesis
All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Without Cancer Who Were Recalled
Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
Measured: upon recruitment/enrollment phase completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2014
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.
- Other trials for Breast AbnormalitiesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jules Sumkin, University of Pittsburgh
- Investigators
- Jules H Sumkin, DO, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106911
- Sponsor's protocol ID
- PRO09060334
- Status last verified
- Feb 2016
- First submitted
- 16 Apr 2010
- Last updated
- 25 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
- ClinicalTrials.gov ID
- NCT01106911
- Acronym / sponsor ID
- PRO09060334
- Conditions
- Breast Abnormalities
- Keywords
- digital breast tomosynthesis, baseline screening mammography, recall rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2014 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Posted 25 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.
Detailed description
The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women between the ages of 34 and 56.
- Women presenting for their baseline screening mammography examination
Key exclusion criteria (6 listed)
- Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
- Women who may be or are pregnant by self report
- Women older than 55 years of age or younger than 35.
- Women with known fatty breast tissue
- Males and children
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 |
|---|---|---|
| tomosynthesis and screening mammographyAlso: digital breast tomosynthesisAll eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis. | Device | – |
Primary outcome
Number of Participants Without Cancer Who Were Recalled
Time frame: upon recruitment/enrollment phase completion
Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jules H Sumkin, DO principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tomosynthesis and screening mammography in people with Breast Abnormalities, run by University of Pittsburgh 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 2 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 25 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2016). 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?
Number of Participants Without Cancer Who Were Recalled (time frame: upon recruitment/enrollment phase completion). 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 25 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.