Clinical trial NCT01236781: Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Official title: Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
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
Lead sponsor: American College of Radiology
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2010-11-09
Enrollment: 558
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Recall Rate in Group A Participants
timeFrame: at the first imaging session
Secondary outcomes:
measure: Accuracy Based on Pathology Results
timeFrame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
measure: Accuracy, Based on Pathology Results, by Lesion Classification
timeFrame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
measure: 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)
timeFrame: At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure)
measure: Radiation Dose
timeFrame: at the first imaging session
measure: Regression Model Parameters for Factors Effecting Radiation Dose
timeFrame: at the first imaging session
measure: Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
timeFrame: At the Diagnostic workup (within 30 Days After Screening)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albery Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Hospital of University of Pennsylvania
name: Emily F. Conant, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Chen 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.