Breast Neoplasms
Conditions
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
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.
Interventions
DEVICEScreening Tomosynthesis
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
DEVICEDiagnostic Tomosynthesis
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
Sponsors
Pennsylvania Department of Health
American College of Radiology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recall Rate in Group A Participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy, Based on Pathology Results, by Lesion Classification | at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome) | 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. |
| 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) | At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure) | 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) |
| Accuracy Based on Pathology Results | at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome) | 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) |
| Regression Model Parameters for Factors Effecting Radiation Dose | at the first imaging session | 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. |
| Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | At the Diagnostic workup (within 30 Days After Screening) | 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. |
| Radiation Dose | at the first imaging session | Radiation dose by modality (FFDM & DBT2D/3D) Dose obtained from the data contained in the acquisition DICOM headers. |
Countries
United States
Participant flow
Recruitment details
Asymptomatic women 25 years and older were accrued between 1/4/2011 and 1/10/2012 at Albert Einstein Med Ctr & U Pennsylvania School of Med. 2-D FFDM and tomosynthesis images were acquired using Hologic digital mammography units. (Group A). An additional set of Women called back from screening for 2-D FFDM-detected abnormalities were recruited for an enriched population (Group B) \[up to 50\]
Pre-assignment details
Study will over-accrue until 550 eligible cases are available
Participants by arm
| Arm | Count |
|---|---|
| Group A: Screening Asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM.
Screening Tomosynthesis: Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set). | 508 |
| Group B: Diagnostic Enriched Population 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).
Diagnostic Tomosynthesis: Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set). | 50 |
| Total | 558 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete study imaging | 5 | 0 |
| Overall Study | Ineligible | 2 | 1 |
Baseline characteristics
| Characteristic | Group B: Diagnostic Enriched Population | Total | Group A: Screening |
|---|---|---|---|
| Age, Continuous | 53 years | 55 years | 55 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 9 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 547 Participants | 497 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 251 Participants | 220 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 296 Participants | 277 Participants |
| Sex: Female, Male Female | 50 Participants | 558 Participants | 508 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 501 | 0 / 49 |
| other Total, other adverse events | 0 / 501 | 0 / 49 |
| serious Total, serious adverse events | 0 / 501 | 0 / 49 |
Outcome results
Primary
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.
Time frame: at the first imaging session
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FFDM Read (Group A) | Recall Rate in Group A Participants | Recall for additional diagnostic imaging | 29 Participants |
| FFDM Read (Group A) | Recall Rate in Group A Participants | Routine follow-up | 472 Participants |
| DBT Read (Group A) | Recall Rate in Group A Participants | Recall for additional diagnostic imaging | 34 Participants |
| DBT Read (Group A) | Recall Rate in Group A Participants | Routine follow-up | 467 Participants |
Comparison: To account for the paired nature of the design, McNemar's test will be used to compare the call-back rates.~H0: assumes no difference between the tests (modalities)p-value: 0.46McNemar
Secondary
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)
Time frame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
Population: Malignant and non-malignant are reported in separate rows for the patients so that all accuracy measures can be determined (True Positive\[Sensitivity\], True Negative \[Specificity\], Positive and Negative Predictive values\[PPV,NPV\])
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FFDM Read (Group A) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Positive | 3 Participants |
| FFDM Read (Group A) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Negative | 1 Participants |
| FFDM Read (Group A) | Accuracy Based on Pathology Results | Malignant (pathology) | No exam | 0 Participants |
| FFDM Read (Group A) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Positive | 26 Participants |
| FFDM Read (Group A) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Negative | 471 Participants |
| FFDM Read (Group A) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | No exam | 0 Participants |
| DBT Read (Group A) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | No exam | 0 Participants |
| DBT Read (Group A) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Positive | 31 Participants |
| DBT Read (Group A) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Positive | 3 Participants |
| DBT Read (Group A) | Accuracy Based on Pathology Results | Malignant (pathology) | No exam | 0 Participants |
| DBT Read (Group A) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Negative | 1 Participants |
| DBT Read (Group A) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Negative | 466 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Negative | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy Based on Pathology Results | Malignant (pathology) | No exam | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Positive | 44 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | No exam | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Negative | 1 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Positive | 4 Participants |
| DBT Diagnostic Read (Group B) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Negative | 26 Participants |
| DBT Diagnostic Read (Group B) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | No exam | 1 Participants |
| DBT Diagnostic Read (Group B) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Negative | 0 Participants |
| DBT Diagnostic Read (Group B) | Accuracy Based on Pathology Results | Not-Malignant (pathology) | Read Positive | 18 Participants |
| DBT Diagnostic Read (Group B) | Accuracy Based on Pathology Results | Malignant (pathology) | Read Positive | 4 Participants |
| DBT Diagnostic Read (Group B) | Accuracy Based on Pathology Results | Malignant (pathology) | No exam | 0 Participants |
Secondary
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.
Time frame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)
Population: Malignant and non-malignant (by Pathology) are reported in separate rows for the patients so that all accuracy measures can be determined (True Positive\[Sensitivity\], True Negative \[Specificity\], Positive and Negative Predictive values\[PPV,NPV\])
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled calcification-only | 5 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled not calcification-only | 19 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled calcification-only | 2 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled not calcification-only | 1 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | No Lesions seen with modality | 470 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled calcification-only | 1 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled not calcification-only | 2 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled calcification-only | 0 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled not calcification-only | 0 Participants |
| FFDM Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | No Lesions seen with modality | 1 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled calcification-only | 0 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled not calcification-only | 0 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled not calcification-only | 2 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | No Lesions seen with modality | 464 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled calcification-only | 1 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled not calcification-only | 2 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | No Lesions seen with modality | 1 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled calcification-only | 0 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled calcification-only | 4 Participants |
| DBT Read (Group A) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled not calcification-only | 27 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled calcification-only | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled not calcification-only | 1 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | No Lesions seen with modality | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled calcification-only | 14 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled not calcification-only | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled calcification-only | 3 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled not calcification-only | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled calcification-only | 0 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | No Lesions seen with modality | 1 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled not calcification-only | 30 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | No Lesions seen with modality | 1 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled calcification-only | 0 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled calcification-only | 3 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | No Lesions seen with modality | 0 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled not calcification-only | 10 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Recalled not calcification-only | 1 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled calcification-only | 6 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Not-Recalled not calcification-only | 20 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Non-malignant | Recalled calcification-only | 8 Participants |
| DBT Diagnostic Read (Group B) | Accuracy, Based on Pathology Results, by Lesion Classification | Malignant | Not-Recalled not calcification-only | 0 Participants |
Secondary
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)
Time frame: At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FFDM Read (Group A) | 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) | Recall for additional diagnostic imaging | 34 Participants |
| FFDM Read (Group A) | 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) | Routine follow-up | 467 Participants |
| DBT Read (Group A) | 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) | Routine follow-up | 471 Participants |
| DBT Read (Group A) | 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) | Recall for additional diagnostic imaging | 30 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | 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) | Recall for additional diagnostic imaging | 29 Participants |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | 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) | Routine follow-up | 20 Participants |
| DBT Diagnostic Read (Group B) | 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) | Recall for additional diagnostic imaging | 30 Participants |
| DBT Diagnostic Read (Group B) | 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) | Routine follow-up | 19 Participants |
Comparison: H0: no difference between the 2 modalitiesp-value: 0.2188McNemar
Secondary
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.
Time frame: At the Diagnostic workup (within 30 Days After Screening)
Population: Analysis is base on the lesions found with either viewing method. 1 finding classified as calcifications only in the tomosynthesis plus set was classified as a MASS in the two-view limited tomosynthesis set~1 finding classified as calcifications only in the tomosynthesis plus set was classified as a ASYMMETRY the two-view limited tomosynthesis set
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATION ONLY LESION | Yes | 20 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATION ONLY LESION | No | 55 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | MASS | Yes | 39 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | MASS | No | 36 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | FOCAL ASYMMETRY | Yes | 14 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | FOCAL ASYMMETRY | No | 61 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | ARCHITECTURAL DISTORTION | Yes | 2 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | ARCHITECTURAL DISTORTION | No | 73 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATIONS | Yes | 1 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATIONS | No | 74 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | GLOBAL ASYMMETRY | Yes | 0 lesions |
| FFDM Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | GLOBAL ASYMMETRY | No | 75 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | GLOBAL ASYMMETRY | Yes | 0 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATION ONLY LESION | Yes | 22 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | ARCHITECTURAL DISTORTION | Yes | 2 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATION ONLY LESION | No | 53 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATIONS | No | 74 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | MASS | Yes | 37 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | ARCHITECTURAL DISTORTION | No | 73 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | MASS | No | 38 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | GLOBAL ASYMMETRY | No | 75 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | FOCAL ASYMMETRY | Yes | 18 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | CALCIFICATIONS | Yes | 1 lesions |
| DBT Read (Group A) | Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A) | FOCAL ASYMMETRY | No | 57 lesions |
Secondary
Radiation Dose
Radiation dose by modality (FFDM & DBT2D/3D) Dose obtained from the data contained in the acquisition DICOM headers.
Time frame: at the first imaging session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FFDM Read (Group A) | Radiation Dose | 1.79 mGy | Standard Deviation 65 |
| DBT Read (Group A) | Radiation Dose | 1.39 mGy | Standard Deviation 0.53 |
| Full-Field Digital Mammography (FFDM) Screening Read (Group B) | Radiation Dose | 1.84 mGy | Standard Deviation 0.55 |
Secondary
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.
Time frame: at the first imaging session
Population: Dose and associated parameters were pulled from each collected images DICOM header.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Intercept | -3.1852 regression slope (Betas) | Standard Deviation 0.1045 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Exposure (mAs) | 0.01215 regression slope (Betas) | Standard Deviation 0.000094 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | KVp | 0.1384 regression slope (Betas) | Standard Deviation 0.005604 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: MOLYBDENUM/MOLYBDENUM | 0.8294 regression slope (Betas) | Standard Deviation 0.02557 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: MOLYBDENUM/RHODIUM | 0.5881 regression slope (Betas) | Standard Deviation 0.02698 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: TUNGSTEN/ALUMINUM | NA regression slope (Betas) | — |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: TUNGSTEN/RHODIUM | -0.4400 regression slope (Betas) | Standard Deviation 0.01767 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: TUNGSTEN/SILVER | 0 regression slope (Betas) | Standard Deviation 0 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Compression Force (N) | 0.000691 regression slope (Betas) | Standard Deviation 0.00009 |
| FFDM Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Breast thickness(mm) | -0.01328 regression slope (Betas) | Standard Deviation 0.001096 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: TUNGSTEN/SILVER | 0 regression slope (Betas) | Standard Deviation 0 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Intercept | -5.3837 regression slope (Betas) | Standard Deviation 0.08977 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: TUNGSTEN/ALUMINUM | 0.3502 regression slope (Betas) | Standard Deviation 0.02885 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Exposure (mAs) | 0.009873 regression slope (Betas) | Standard Deviation 0.000103 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Breast thickness(mm) | -0.01362 regression slope (Betas) | Standard Deviation 0.001125 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | KVp | 0.2180 regression slope (Betas) | Standard Deviation 0.005328 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: TUNGSTEN/RHODIUM | -0.1986 regression slope (Betas) | Standard Deviation 0.01981 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: MOLYBDENUM/MOLYBDENUM | NA regression slope (Betas) | — |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Compression Force (N) | 0.000241 regression slope (Betas) | Standard Deviation 0.000099 |
| DBT Read (Group A) | Regression Model Parameters for Factors Effecting Radiation Dose | Anode/Filter: MOLYBDENUM/RHODIUM | NA regression slope (Betas) | — |