Breast NeoplasmsNCT01236781
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
A study testing Screening Tomosynthesis and Diagnostic Tomosynthesis in people with Breast Neoplasms, run by American College of Radiology at 2 sites in United States.
Trial summary
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Screening Tomosynthesis and Diagnostic Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2011to 31 Dec 2013
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 25 years of age or older;
- No history of breast cancer;
- Group A only: Asymptomatic and scheduled for screening mammography;
- Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed);
- Willing to provide a written informed consent.
Who cannot join
- Pregnancy or intent to become pregnant;
- Unable or unwilling to tolerate compression associated with mammography;
- Breast implants;
- Breasts too large to allow for adequate positioning for the DBT examination;
- Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN;
- Group B only: Unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings;
- Unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility;
- Tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for Group B).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19118
Albery Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be measured by the participant call-back rate by each modality. Varying combinations of 2-D mammography and tomosynthesis projections will be evaluated to optimize the screening paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective and retrospective imaging data will be assessed.
Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection. This improved accuracy will be achieved by the optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence.
Read the detailed description
Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography (Group A). A similar population of women called back from screening for 2-D FFDM-detected abnormalities will also be recruited to provide an enriched population of true-positive and false-positive 2-D FFDM and tomosynthesis cases (Group B). Pregnant women, women unable to tolerate compression of the breast associated with mammography, women with implants, and women with breasts too large to accommodate adequate positioning of the breast for DBT are excluded from trial participation.
A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial (Group A); 50 additional participants, recalled for diagnostic assessment after positive screening findings, will be recruited for DBT imaging data collection and retrospective image analysis (Group B). Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units.
- Conditions
- Breast Neoplasms
- Being tested
- Screening Tomosynthesis, Diagnostic Tomosynthesis
- Keywords
- breast cancer, screening, diagnostics, diagnosis, high-risk, breast neoplasms, digital mammography, mammography, tomosynthesis, dense breasts, radiation dose, comparison, Hologic, Pennsylvania, Philadelphia, breast study, mammo, tomo, mammary
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening TomosynthesisDevice
Also called Hologic, Dimension
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
Diagnostic TomosynthesisDevice
Also called Hologic, Dimension
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Screening | Experimental | Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM. Receives: Device: Screening Tomosynthesis |
| Group B: Diagnostic Enriched Population | Experimental | Approximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other). Receives: Device: Diagnostic Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall Rate in Group A Participants
Each participant will undergo both FFDM and DBT examinations. Each of the two exams will be interpreted separately by readers at the participating sites and any positive finding for diagnostic followup will be considered a recall.
Measured: at the first imaging session
Secondary outcomes (6)
Accuracy Based on Pathology Results
Malignant pathologic results will be used to determine Accuracy (True Positive[Sensitivity], True Negative [Specificity], Positive and Negative Predictive values[PPV,NPV]) of FFDM and limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Groups A and B].
A Positive screening read had an overall site recommendation of additional Workup A Positive diagnostic read is defined as either Breast having a BIRADs score of 4 or 5 on the diagnostic read (where high BIRADS indicates higher confidence of malignancy)
Measured: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
Accuracy, Based on Pathology Results, by Lesion Classification
Malignancy determined by pathology and follow-up will be used to determine Accuracy (True Positive[Sensitivity], True Negative [Specificity], Positive and Negative Predictive values[PPV,NPV]) of FFDM and limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) with results reported by lesion-type characterization (calcification-only lesions versus soft-tissue lesions,)[Groups A and B].
A Positive screening read had an overall site recommendation of additional screening A Positive diagnostic read is defined as either Breast having a BIRADs score of 4 or 5 on the diagnostic read.
Measured: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
Callback Rate of Two-view Limited Tomosynthesis Set (With Low-dose MLO View Alone) With the Tomosynthesis Plus Set (Low-dose MLO View Plus Addition of Low-dose CC View)
Sequential interpretation results for call- back from two-view limited tomosynthesis set (with low-dose MLO view alone) and tomosynthesis plus set (low-dose MLO view plus addition of low-dose CC view)
Measured: At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure)
Radiation Dose
Radiation dose by modality (FFDM \& DBT2D/3D) Dose obtained from the data contained in the acquisition DICOM headers.
Measured: at the first imaging session
Regression Model Parameters for Factors Effecting Radiation Dose
a mixed Regression Model to identify the determinants of participant radiation dose, including covariates (X) such as: kVp, mAs, target/filter combination, and breast thickness and compression.
Dose = B1*X1 + B2*X2 + B3*X3 + ...
The outcome measures is are the estimated coefficients (B) of the covariate (X) in the mixed regression model.
The coefficient (B) of the term (X) represents the change in the mean response (dose) for one unit of change in that term. If the coefficient is negative, as the term increases, the mean value of the response decreases. If the coefficient is positive, as the term increases, the mean value of the response increases.
Note: the TUNGSTEN/SILVER categorical target/filter combination is used as the reference category and will have a parameter value of 0.
Measured: at the first imaging session
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
Group A, screening tomosynthesis, cases will be evaluated using 2 methodologies. Readers will read each screening exams using either (1) the limited tomosynthesis set (with low-dose MLO view alone) or (2) the tomosynthesis plus set (low-dose MLO view plus addition of low-dose CC view) and classify the lesions they are able to visualize per SOC.
SOC Lesions characterizations include: Calcification Only lesion , Mass, Focal Asymmetry, Architectural Distortion, Global Asymmetry, Calcification) The characterizations will be tabulated by whether or not each lesion was classified in the given category.
Measured: At the Diagnostic workup (within 30 Days After Screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study start4 Jan 2011
- Primary completionJun 2012
- Study completion31 Dec 2013
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Emily F. Conant, MD, Study chair, Hospital of University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236781
- Sponsor's protocol ID
- ACRIN PA 4006
- Status last verified
- Feb 2025
- First submitted
- 5 Nov 2010
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ray S, Chen L, Keller BM, Chen J, Conant EF, Kontos D. Association between Breast Parenchymal Complexity and False-Positive Recall From Digital Mammography Versus Breast Tomosynthesis: Preliminary Investigation in the ACRIN PA 4006 Trial. Acad Radiol. 2016 Aug;23(8):977-86. doi: 10.1016/j.acra.2016.02.019. Epub 2016 May 25.
PubMed 27236612Chen L, Ray S, Keller BM, Pertuz S, McDonald ES, Conant EF, Kontos D. The Impact of Acquisition Dose on Quantitative Breast Density Estimation with Digital Mammography: Results from ACRIN PA 4006. Radiology. 2016 Sep;280(3):693-700. doi: 10.1148/radiol.2016151749. Epub 2016 Mar 22.
PubMed 27002418
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
- ClinicalTrials.gov ID
- NCT01236781
- Acronym / sponsor ID
- ACRIN PA 4006
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, screening, diagnostics, diagnosis, high-risk, breast neoplasms, digital mammography, mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- 4 Jan 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be measured by the participant call-back rate by each modality. Varying combinations of 2-D mammography and tomosynthesis projections will be evaluated to optimize the screening paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective and retrospective imaging data will be assessed.
Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection. This improved accuracy will be achieved by the optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence.
Detailed description
Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography (Group A). A similar population of women called back from screening for 2-D FFDM-detected abnormalities will also be recruited to provide an enriched population of true-positive and false-positive 2-D FFDM and tomosynthesis cases (Group B). Pregnant women, women unable to tolerate compression of the breast associated with mammography, women with implants, and women with breasts too large to accommodate adequate positioning of the breast for DBT are excluded from trial participation.
A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial (Group A); 50 additional participants, recalled for diagnostic assessment after positive screening findings, will be recruited for DBT imaging data collection and retrospective image analysis (Group B). Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Screening | Experimental | Device: Screening TomosynthesisGroup A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM. |
| Group B: Diagnostic Enriched Population | Experimental | Device: Diagnostic TomosynthesisApproximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other). |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women 25 years of age or older;
- No history of breast cancer;
- Group A only: Asymptomatic and scheduled for screening mammography;
- Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed);
- Willing to provide a written informed consent.
Key exclusion criteria (8 listed)
- Pregnancy or intent to become pregnant;
- Unable or unwilling to tolerate compression associated with mammography;
- Breast implants;
- Breasts too large to allow for adequate positioning for the DBT examination;
- Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN;
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 |
|---|---|---|
| Screening TomosynthesisAlso: Hologic, DimensionTomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set). | Device | Group A: Screening |
| Diagnostic TomosynthesisAlso: Hologic, DimensionTomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set). | Device | Group B: Diagnostic Enriched Population |
Primary outcome
Recall Rate in Group A Participants
Time frame: at the first imaging session
Each participant will undergo both FFDM and DBT examinations. Each of the two exams will be interpreted separately by readers at the participating sites and any positive finding for diagnostic followup will be considered a recall.
6 secondary outcomes
Accuracy Based on Pathology Results
Time frame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
Accuracy, Based on Pathology Results, by Lesion Classification
Time frame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
Callback Rate of Two-view Limited Tomosynthesis Set (With Low-dose MLO View Alone) With the Tomosynthesis Plus Set (Low-dose MLO View Plus Addition of Low-dose CC View)
Time frame: At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure)
Radiation Dose
Time frame: at the first imaging session
Regression Model Parameters for Factors Effecting Radiation Dose
Time frame: at the first imaging session
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
Time frame: At the Diagnostic workup (within 30 Days After Screening)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27236612Ray S, Chen L, Keller BM, Chen J, Conant EF, Kontos D. Association between Breast Parenchymal Complexity and False-Positive Recall From Digital Mammography Versus Breast Tomosynthesis: Preliminary Investigation in the ACRIN PA 4006 Trial. Acad Radiol. 2016 Aug;23(8):977-86. doi: 10.1016/j.acra.2016.02.019. Epub 2016 May 25.
- Results publication: PubMed 27002418Chen L, Ray S, Keller BM, Pertuz S, McDonald ES, Conant EF, Kontos D. The Impact of Acquisition Dose on Quantitative Breast Density Estimation with Digital Mammography: Results from ACRIN PA 4006. Radiology. 2016 Sep;280(3):693-700. doi: 10.1148/radiol.2016151749. Epub 2016 Mar 22.
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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.
Emily F. Conant, MD study chair
Hospital of University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Tomosynthesis and Diagnostic Tomosynthesis in people with Breast Neoplasms, run by American College of Radiology at 2 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 5 inclusion and 8 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 5 Mar 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?
Recall Rate in Group A Participants (time frame: at the first imaging session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236781, which also lists 2 linked publications.
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 5 Mar 2025.