Trial Outcomes & Findings for Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates (NCT NCT01236781)
NCT ID: NCT01236781
Last Updated: 2025-03-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
558 participants
Primary outcome timeframe
at the first imaging session
Results posted on
2025-03-05
Participant Flow
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) \[up to 50\]
Study will over-accrue until 550 eligible cases are available
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
508
|
50
|
|
Overall Study
COMPLETED
|
501
|
49
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Ineligible
|
2
|
1
|
|
Overall Study
Did not complete study imaging
|
5
|
0
|
Baseline Characteristics
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Baseline characteristics by cohort
| Measure |
Group A: Screening
n=508 Participants
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).
|
Group B: Diagnostic Enriched Population
n=50 Participants
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).
|
Total
n=558 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
53 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
508 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
558 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
497 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
547 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
220 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
277 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the first imaging sessionEach 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.
Outcome measures
| Measure |
FFDM Read (Group A)
n=501 Participants
Full-Field Digital Mammography (FFDM) images were read locally by a reader blinded to the results of the Digital Breast Tomography (DBT) results
|
DBT Read (Group A)
n=501 Participants
Digital Breast Tomography (DBT) images were read locally by a reader blinded to the results of the Full-Field Digital Mammography (FFDM) results
|
Full-Field Digital Mammography (FFDM) Screening Read (Group B)
FFDM Screening Read results for 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.
Screening Read Positive = Recall for additional imaging
|
DBT Diagnostic Read (Group B)
DBT Diagnostic results for 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.
Diagnostic Read Positive =BIRADS 4 or 5
|
|---|---|---|---|---|
|
Recall Rate in Group A Participants
Recall for additional diagnostic imaging
|
29 Participants
|
34 Participants
|
—
|
—
|
|
Recall Rate in Group A Participants
Routine follow-up
|
472 Participants
|
467 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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\[PPV,NPV\])
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)
Outcome measures
| Measure |
FFDM Read (Group A)
n=501 Participants
Full-Field Digital Mammography (FFDM) images were read locally by a reader blinded to the results of the Digital Breast Tomography (DBT) results
|
DBT Read (Group A)
n=501 Participants
Digital Breast Tomography (DBT) images were read locally by a reader blinded to the results of the Full-Field Digital Mammography (FFDM) results
|
Full-Field Digital Mammography (FFDM) Screening Read (Group B)
n=49 Participants
FFDM Screening Read results for 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.
Screening Read Positive = Recall for additional imaging
|
DBT Diagnostic Read (Group B)
n=49 Participants
DBT Diagnostic results for 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.
Diagnostic Read Positive =BIRADS 4 or 5
|
|---|---|---|---|---|
|
Accuracy Based on Pathology Results
Malignant (pathology) · Read Positive
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Accuracy Based on Pathology Results
Malignant (pathology) · Read Negative
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Accuracy Based on Pathology Results
Malignant (pathology) · No exam
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Accuracy Based on Pathology Results
Not-Malignant (pathology) · Read Positive
|
26 Participants
|
31 Participants
|
44 Participants
|
18 Participants
|
|
Accuracy Based on Pathology Results
Not-Malignant (pathology) · Read Negative
|
471 Participants
|
466 Participants
|
1 Participants
|
26 Participants
|
|
Accuracy Based on Pathology Results
Not-Malignant (pathology) · No exam
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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\[PPV,NPV\])
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.
Outcome measures
| Measure |
FFDM Read (Group A)
n=501 Participants
Full-Field Digital Mammography (FFDM) images were read locally by a reader blinded to the results of the Digital Breast Tomography (DBT) results
|
DBT Read (Group A)
n=501 Participants
Digital Breast Tomography (DBT) images were read locally by a reader blinded to the results of the Full-Field Digital Mammography (FFDM) results
|
Full-Field Digital Mammography (FFDM) Screening Read (Group B)
n=49 Participants
FFDM Screening Read results for 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.
Screening Read Positive = Recall for additional imaging
|
DBT Diagnostic Read (Group B)
n=49 Participants
DBT Diagnostic results for 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.
Diagnostic Read Positive =BIRADS 4 or 5
|
|---|---|---|---|---|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Non-malignant · Recalled calcification-only
|
5 Participants
|
4 Participants
|
14 Participants
|
8 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Non-malignant · Recalled not calcification-only
|
19 Participants
|
27 Participants
|
30 Participants
|
10 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Non-malignant · Not-Recalled calcification-only
|
2 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Non-malignant · No Lesions seen with modality
|
470 Participants
|
464 Participants
|
1 Participants
|
1 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Malignant · Recalled calcification-only
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Malignant · Recalled not calcification-only
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Malignant · Not-Recalled calcification-only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Malignant · Not-Recalled not calcification-only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Non-malignant · Not-Recalled not calcification-only
|
1 Participants
|
2 Participants
|
0 Participants
|
20 Participants
|
|
Accuracy, Based on Pathology Results, by Lesion Classification
Malignant · No Lesions seen with modality
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
FFDM Read (Group A)
n=501 Participants
Full-Field Digital Mammography (FFDM) images were read locally by a reader blinded to the results of the Digital Breast Tomography (DBT) results
|
DBT Read (Group A)
n=501 Participants
Digital Breast Tomography (DBT) images were read locally by a reader blinded to the results of the Full-Field Digital Mammography (FFDM) results
|
Full-Field Digital Mammography (FFDM) Screening Read (Group B)
n=49 Participants
FFDM Screening Read results for 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.
Screening Read Positive = Recall for additional imaging
|
DBT Diagnostic Read (Group B)
n=49 Participants
DBT Diagnostic results for 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.
Diagnostic Read Positive =BIRADS 4 or 5
|
|---|---|---|---|---|
|
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
|
30 Participants
|
29 Participants
|
30 Participants
|
|
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
|
471 Participants
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: at the first imaging sessionRadiation dose by modality (FFDM \& DBT2D/3D) Dose obtained from the data contained in the acquisition DICOM headers.
Outcome measures
| Measure |
FFDM Read (Group A)
n=2262 views
Full-Field Digital Mammography (FFDM) images were read locally by a reader blinded to the results of the Digital Breast Tomography (DBT) results
|
DBT Read (Group A)
n=1980 views
Digital Breast Tomography (DBT) images were read locally by a reader blinded to the results of the Full-Field Digital Mammography (FFDM) results
|
Full-Field Digital Mammography (FFDM) Screening Read (Group B)
n=1980 views
FFDM Screening Read results for 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.
Screening Read Positive = Recall for additional imaging
|
DBT Diagnostic Read (Group B)
DBT Diagnostic results for 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.
Diagnostic Read Positive =BIRADS 4 or 5
|
|---|---|---|---|---|
|
Radiation Dose
|
1.79 mGy
Standard Deviation 065
|
1.39 mGy
Standard Deviation 0.53
|
1.84 mGy
Standard Deviation 0.55
|
—
|
SECONDARY outcome
Timeframe: at the first imaging sessionPopulation: Dose and associated parameters were pulled from each collected images DICOM header.
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.
Outcome measures
| Measure |
FFDM Read (Group A)
n=2262 Images
Full-Field Digital Mammography (FFDM) images were read locally by a reader blinded to the results of the Digital Breast Tomography (DBT) results
|
DBT Read (Group A)
n=3951 Images
Digital Breast Tomography (DBT) images were read locally by a reader blinded to the results of the Full-Field Digital Mammography (FFDM) results
|
Full-Field Digital Mammography (FFDM) Screening Read (Group B)
FFDM Screening Read results for 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.
Screening Read Positive = Recall for additional imaging
|
DBT Diagnostic Read (Group B)
DBT Diagnostic results for 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.
Diagnostic Read Positive =BIRADS 4 or 5
|
|---|---|---|---|---|
|
Regression Model Parameters for Factors Effecting Radiation Dose
KVp
|
0.1384 regression slope (Betas)
Standard Deviation 0.005604
|
0.2180 regression slope (Betas)
Standard Deviation 0.005328
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Anode/Filter: MOLYBDENUM/MOLYBDENUM
|
0.8294 regression slope (Betas)
Standard Deviation 0.02557
|
NA regression slope (Betas)
Standard Deviation NA
This anode/filter combination was not used
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Anode/Filter: TUNGSTEN/RHODIUM
|
-0.4400 regression slope (Betas)
Standard Deviation 0.01767
|
-0.1986 regression slope (Betas)
Standard Deviation 0.01981
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Compression Force (N)
|
0.000691 regression slope (Betas)
Standard Deviation 0.000090
|
0.000241 regression slope (Betas)
Standard Deviation 0.000099
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Breast thickness(mm)
|
-0.01328 regression slope (Betas)
Standard Deviation 0.001096
|
-0.01362 regression slope (Betas)
Standard Deviation 0.001125
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Intercept
|
-3.1852 regression slope (Betas)
Standard Deviation 0.1045
|
-5.3837 regression slope (Betas)
Standard Deviation 0.08977
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Exposure (mAs)
|
0.01215 regression slope (Betas)
Standard Deviation 0.000094
|
0.009873 regression slope (Betas)
Standard Deviation 0.000103
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Anode/Filter: MOLYBDENUM/RHODIUM
|
0.5881 regression slope (Betas)
Standard Deviation 0.02698
|
NA regression slope (Betas)
Standard Deviation NA
This anode/filter combination was not used
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Anode/Filter: TUNGSTEN/ALUMINUM
|
NA regression slope (Betas)
Standard Deviation NA
This anode/filter combination was not used
|
0.3502 regression slope (Betas)
Standard Deviation 0.02885
|
—
|
—
|
|
Regression Model Parameters for Factors Effecting Radiation Dose
Anode/Filter: TUNGSTEN/SILVER
|
0 regression slope (Betas)
Standard Deviation 0
|
0 regression slope (Betas)
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
FFDM Read (Group A)
n=75 lesions
Full-Field Digital Mammography (FFDM) images were read locally by a reader blinded to the results of the Digital Breast Tomography (DBT) results
|
DBT Read (Group A)
n=75 lesions
Digital Breast Tomography (DBT) images were read locally by a reader blinded to the results of the Full-Field Digital Mammography (FFDM) results
|
Full-Field Digital Mammography (FFDM) Screening Read (Group B)
FFDM Screening Read results for 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.
Screening Read Positive = Recall for additional imaging
|
DBT Diagnostic Read (Group B)
DBT Diagnostic results for 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.
Diagnostic Read Positive =BIRADS 4 or 5
|
|---|---|---|---|---|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
CALCIFICATION ONLY LESION · Yes
|
20 lesions
|
22 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
MASS · Yes
|
39 lesions
|
37 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
MASS · No
|
36 lesions
|
38 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
FOCAL ASYMMETRY · No
|
61 lesions
|
57 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
ARCHITECTURAL DISTORTION · No
|
73 lesions
|
73 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
CALCIFICATIONS · Yes
|
1 lesions
|
1 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
GLOBAL ASYMMETRY · Yes
|
0 lesions
|
0 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
GLOBAL ASYMMETRY · No
|
75 lesions
|
75 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
CALCIFICATION ONLY LESION · No
|
55 lesions
|
53 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
FOCAL ASYMMETRY · Yes
|
14 lesions
|
18 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
ARCHITECTURAL DISTORTION · Yes
|
2 lesions
|
2 lesions
|
—
|
—
|
|
Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)
CALCIFICATIONS · No
|
74 lesions
|
74 lesions
|
—
|
—
|
Adverse Events
Asymptomatic Women (Screening) - Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enriched Cohort - Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director Clinical Research Administration
American College of Radiology
Phone: 215-574-3150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place