Breast CancerNCT01569802
A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population
An observational study of Breast Cancer, run by Rose Imaging Specialists, P.A. at 1 site in United States.
Trial summary
The primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases. 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
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to not given
- 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: radiology clinic screening population
Who may be able to join
- Subject is female of any race and ethnicity
- The subject is asymptomatic and presents for routine screening mammography and chooses to have a combination 2D + 3D mammogram as her standard of care.
Who cannot join
- Patient chooses standard 2D mammography over a combination 2D + 3D mammogram
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
TOPS
Houston, Texas, 77090
Andra Tidwell, RT(R)(M), 281-580-6171, atidwell@uspi.com
About this study
The primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases.
- Conditions
- Breast Cancer
- Keywords
- breast cancer screening, tomosynthesis, FFDM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| screening | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall Rate
measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population
Measured: up to 1 year
Secondary outcomes (1)
Cancer detection Rate
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startJan 2012
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.
- 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rose Imaging Specialists, P.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569802
- Sponsor's protocol ID
- 11-02
- Status last verified
- Mar 2012
- First submitted
- 29 Mar 2012
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population
- ClinicalTrials.gov ID
- NCT01569802
- Acronym / sponsor ID
- 11-02
- Conditions
- Breast Cancer
- Keywords
- breast cancer screening, tomosynthesis, FFDM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Rose Imaging Specialists, P.A.University, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- Jan 2012
- First posted
- 3 Apr 2012 (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 primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- radiology clinic screening population
Key inclusion criteria (2 listed)
- Subject is female of any race and ethnicity
- The subject is asymptomatic and presents for routine screening mammography and chooses to have a combination 2D + 3D mammogram as her standard of care.
Key exclusion criteria (1 listed)
- Patient chooses standard 2D mammography over a combination 2D + 3D mammogram
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
Recall Rate
Time frame: up to 1 year
measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population
1 secondary outcome
Cancer detection Rate
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
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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.
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 Rose Imaging Specialists, P.A. 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 1 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: status not confirmed, as of the sponsor's last update on 3 Apr 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall Rate (time frame: up to 1 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 3 Apr 2012.