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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening Tomosynthesis | Device | Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at the first imaging session |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily F. Conant, MD | Hospital of University of Pennsylvania | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19118 | United States | ||
| Albery Einstein Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27236612 | Background | 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. | |
| 27002418 |
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Study will over-accrue until 550 eligible cases are available
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]
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| ID | Title | Description |
|---|---|---|
| FG000 | Asymptomatic Women (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). |
| FG001 | Enriched Diagnostic DBT Followup (Group B) | 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). Group B participants will consent to DBT of both breasts as part of their diagnostic imaging work up; all screening and diagnostic images will be collected for study-related analysis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | at the first imaging session |
|
30 days from screening imaging visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asymptomatic Women (Screening) - Group A | Asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research Administration | American College of Radiology | 215-574-3150 | info@acr.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2010 | Nov 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2010 | Nov 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014716 | Vertical Dimension |
| ID | Term |
|---|---|
| D003768 | Dental Occlusion, Centric |
| D003766 | Dental Occlusion |
| D003813 | Dentistry |
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|
| Diagnostic Tomosynthesis | Device | Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set). |
|
|
| 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. | 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) | 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. | 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. | 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. | At the Diagnostic workup (within 30 Days After Screening) |
| Philadelphia |
| Pennsylvania |
| 19141 |
| United States |
| 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. |
| 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| 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) | 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]) | Posted | Count of Participants | Participants | at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome) |
|
|
|
| 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. | 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]) | Posted | Count of Participants | Participants | at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome) |
|
|
|
| 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) | Posted | Count of Participants | Participants | At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure) |
|
|
|
|
| Secondary | Radiation Dose | Radiation dose by modality (FFDM & DBT2D/3D) Dose obtained from the data contained in the acquisition DICOM headers. | Posted | Mean | Standard Deviation | mGy | at the first imaging session | views | views |
|
|
|
| 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. | Dose and associated parameters were pulled from each collected images DICOM header. | Posted | Mean | Standard Deviation | regression slope (Betas) | at the first imaging session | Images | Images |
|
|
|
| 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. | 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 | Posted | Count of Units | lesions | At the Diagnostic workup (within 30 Days After Screening) | lesions | lesions |
|
|
|
| 0 |
| 501 |
| 0 |
| 501 |
| 0 |
| 501 |
| EG001 | Enriched Cohort - Group B | 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] Asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening. Group B participants will consent to DBT of both breasts as part of their diagnostic imaging work up | 0 | 49 | 0 | 49 | 0 | 49 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Not-Malignant (pathology) |
|
|
|
| Malignant |
|
|
| Routine follow-up |
|
| KVp |
|
| Anode/Filter: MOLYBDENUM/MOLYBDENUM |
|
| Anode/Filter: MOLYBDENUM/RHODIUM |
|
| Anode/Filter: TUNGSTEN/ALUMINUM |
|
| Anode/Filter: TUNGSTEN/RHODIUM |
|
| Anode/Filter: TUNGSTEN/SILVER |
|
| Compression Force (N) |
|
| Breast thickness(mm) |
|
| MASS |
|
| FOCAL ASYMMETRY |
|
| ARCHITECTURAL DISTORTION |
|
| CALCIFICATIONS |
|
| GLOBAL ASYMMETRY |
|
| Read Negative |
|
| No exam |
|
| Recalled not calcification-only |
|
| Not-Recalled calcification-only |
|
| Not-Recalled not calcification-only |
|
| No Lesions seen with modality |
|