Breast CancerNCT00971087
Multicenter Hologic Tomosynthesis Study
A study testing Hologic Selenia Dimensions Digital Breast Tomosynthesis System in people with Breast Cancer, run by Hologic, Inc. at 22 sites in United States.
Trial summary
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hologic Selenia Dimensions Digital Breast Tomosynthesis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,521 participants
- Where
- 22 sitesUnited States
- Study dates
- Sep 2009to Apr 2012
- 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 18 to 110 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Any ethnic origin
- No contraindication of routine bilateral mammography
Who cannot join
- Any contraindications to mammographic screening, including but not limited to:
- Significant existing breast trauma
- Pregnancy
- Lactating
- Previous surgical biopsy
- Previous breast cancer
Show all 10Show fewer
- Placement of an internal breast marker
- Breast implants
- Unable to understand and execute written informed consent
- Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Boca Raton Community Hospital
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Fletcher Allen Health Care
Burlington, Vermont, 05401
University of Virginia
Charlottesville, Virginia, 22908
Luthern General - Advocate Health Care
Chicago, Illinois, 60068
University of Cincinnati
Cincinnati, Ohio, 45912
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
UTSW Center for Breast Care
Dallas, Texas, 75039
Spectrum Health
Grand Rapids, Michigan, 49503
Invision/Sally Jobe
Greenwood Village, Colorado, 80111
Memorial Florida
Hollywood, Florida, 33021
Memorial Hermann/ Memorial City
Houston, Texas, 77074
Intermountain Medical Imaging
Murray, Utah, 84175
Hoag Memorial Hospital
Newport Beach, California, 92663
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Elizabeth Wende Breast Clinic
Rochester, New York, 14620
UC Davis
Sacramento, California, 95817
Scottsdale Medical Imaging Ltd. (SMIL)
Scottsdale, Arizona, 85251
Barnes Jewish
St Louis, Missouri, 63110
York - Women's Imaging at Apple Hill
York, Pennsylvania, 17403
About this study
Official title: A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
- Conditions
- Breast Cancer
- Being tested
- Hologic Selenia Dimensions Digital Breast Tomosynthesis System
- Keywords
- Breast cancer, breast cancer screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hologic Selenia Dimensions Digital Breast Tomosynthesis SystemDevice
Also called Tomosynthesis, Tomo, Breast tomosynthesis, 3D Breast imaging
Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure.
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing breast cancer screening | Other | The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy Receives: Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.
ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.
Measured: At time of exam
Secondary outcomes (2)
Analysis of ROC Performance in Subjects With Dense Breasts
The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4).
Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference.
Measured: At time of exam
Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM
The non-cancer recall rate was measured for 3DS and 2D FFDM
Measured: at time of exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionApr 2012
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971087
- Sponsor's protocol ID
- 09-03
- Status last verified
- Feb 2025
- First submitted
- 2 Sep 2009
- Last updated
- 26 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
- ClinicalTrials.gov ID
- NCT00971087
- Acronym / sponsor ID
- 09-03
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, breast cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,521 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing breast cancer screening | Other | Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis SystemThe study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Any ethnic origin
- No contraindication of routine bilateral mammography
Key exclusion criteria (10 listed)
- Any contraindications to mammographic screening, including but not limited to:
- Significant existing breast trauma
- Pregnancy
- Lactating
- Previous surgical biopsy
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 |
|---|---|---|
| Hologic Selenia Dimensions Digital Breast Tomosynthesis SystemAlso: Tomosynthesis, Tomo, Breast tomosynthesis, 3D Breast imagingSubjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure. | Device | Subjects undergoing breast cancer screening |
Primary outcome
To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.
Time frame: At time of exam
ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.
2 secondary outcomes
Analysis of ROC Performance in Subjects With Dense Breasts
Time frame: At time of exam
Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM
Time frame: at time of exam
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hologic Selenia Dimensions Digital Breast Tomosynthesis System in people with Breast Cancer, run by Hologic, Inc. at 22 sites 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 10 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 26 Feb 2025). 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?
To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images. (time frame: At time of exam). 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 26 Feb 2025.