Trial Outcomes & Findings for Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts (NCT NCT02933489)
NCT ID: NCT02933489
Last Updated: 2025-03-10
Results Overview
For each modality, the detection rate of invasive cancers is defined as the proportion of participants who had an invasive cancer detected by the modality at baseline and verified by pathology versus the total number of participants. In the out come measures table below, these proportions will be automatically calculated, multiplied by 100, and be presented as percentages (%).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1516 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2025-03-10
Participant Flow
Women with dense breasts scheduled for routine screening with DBT were enrolled to receive DBT and AB-MR, with scan order determined by randomization. The first subject was accrued on December 27, 2016, and accrual ended on November 10, 2017. A total of 48 institutions participated.
Participant milestones
| Measure |
Arm A (DBT, AB-MR)
Participants undergo DBT followed by AB-MR, for under 10 minutes, on the same day or within 24 hours at baseline and then after 1 year.
AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography
|
Arm B (AB-MR, DBT)
Participants undergo AB-MR, for under 10 minutes, followed by DBT on the same day or within 24 hours at baseline and then after 1 year.
AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography
|
|---|---|---|
|
Overall Study
STARTED
|
757
|
759
|
|
Overall Study
DBTperformed
|
726
|
737
|
|
Overall Study
AB MR Performed
|
713
|
733
|
|
Overall Study
DCIS Detected
|
5
|
6
|
|
Overall Study
PAM50 NanoString
|
0
|
0
|
|
Overall Study
COMPLETED
|
713
|
731
|
|
Overall Study
NOT COMPLETED
|
44
|
28
|
Reasons for withdrawal
| Measure |
Arm A (DBT, AB-MR)
Participants undergo DBT followed by AB-MR, for under 10 minutes, on the same day or within 24 hours at baseline and then after 1 year.
AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography
|
Arm B (AB-MR, DBT)
Participants undergo AB-MR, for under 10 minutes, followed by DBT on the same day or within 24 hours at baseline and then after 1 year.
AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography
|
|---|---|---|
|
Overall Study
Ineligible
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
27
|
18
|
|
Overall Study
Unable to complete exams (other)
|
14
|
7
|
Baseline Characteristics
Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts
Baseline characteristics by cohort
| Measure |
Arm A (DBT, AB-MR)
n=757 Participants
Participants undergo DBT followed by AB-MR, for under 10 minutes, on the same day or within 24 hours at baseline and then after 1 year.
AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography
|
Arm B (AB-MR, DBT)
n=759 Participants
Participants undergo AB-MR, for under 10 minutes, followed by DBT on the same day or within 24 hours at baseline and then after 1 year.
AB-MR: Contrast-enhanced Abbreviated Magnetic Resonance Imaging (MRI) DBT: Digital Tomosynthesis Mammography
|
Total
n=1516 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
757 Participants
n=5 Participants
|
759 Participants
n=7 Participants
|
1516 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
704 Participants
n=5 Participants
|
678 Participants
n=7 Participants
|
1382 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
42 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
648 Participants
n=5 Participants
|
639 Participants
n=7 Participants
|
1287 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Menopausal Status
Pre-menopausal
|
236 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
442 Participants
n=5 Participants
|
|
Menopausal Status
Peri-menopausal
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Menopausal Status
Naturally post-menopausal
|
316 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
671 Participants
n=5 Participants
|
|
Menopausal Status
Surgically post-menopausal
|
114 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Menopausal Status
Unknown (data not available)
|
42 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Breast density (baseline DBT)
Almost entirely fat
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Breast density (baseline DBT)
Scattered fibroglandular densities
|
50 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Breast density (baseline DBT)
Heterogeneously dense
|
564 Participants
n=5 Participants
|
564 Participants
n=7 Participants
|
1128 Participants
n=5 Participants
|
|
Breast density (baseline DBT)
Extremely dense
|
113 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Breast density (baseline DBT)
Scan not performed
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Prior personal history of breast cancer
No
|
724 Participants
n=5 Participants
|
728 Participants
n=7 Participants
|
1452 Participants
n=5 Participants
|
|
Prior personal history of breast cancer
Yes
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Prior personal history of breast cancer
Unknown
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Subjects with both DBT and AB-MR
For each modality, the detection rate of invasive cancers is defined as the proportion of participants who had an invasive cancer detected by the modality at baseline and verified by pathology versus the total number of participants. In the out come measures table below, these proportions will be automatically calculated, multiplied by 100, and be presented as percentages (%).
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=1444 Participants
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
n=1444 Participants
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Screen-detected Invasive Cancer Verified by Pathology
Invasive Cancer Detected
|
7 Participants
|
17 Participants
|
—
|
—
|
|
Screen-detected Invasive Cancer Verified by Pathology
No Invasive Cancer Detected
|
1437 Participants
|
1427 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to up to 1 yearPopulation: Positive predictive value is calculated on patients with at least one lesion rated BI-RADS 4 or 5 on image interpretation (I.e., Biopsy recommended) and is the percentage of biopsy recommended by imaging test versus patients with cancer P(D+\|T+)
Test Positive (T+): Biopsy recommended by imaging, defined as patients with at least one lesion rated BI-RADS 4 or 5 on image interpretation. Reference Standard Positive (RS+): Pathologically confirmed DCIS or invasive disease resultant from a positive test. The 95% confidence interval for PPV of biopsy for each modality were derived from the GEE model using the appropriate estimable contrasts with robust standard errors
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=29 Cases recommended for biopsy by imaging
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
n=107 Cases recommended for biopsy by imaging
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Positive Predictive Value (PPV) of Biopsies
|
31.0 percentage of Biopsy Recommended
Interval 17.0 to 49.7
|
19.6 percentage of Biopsy Recommended
Interval 13.2 to 28.2
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselineFor DBT: DBT: Call back is defined as having additional views or targeted ultrasound to evaluate DBT findings DBT: short term follow up (STFU) is defined as having at least one lesion rated BI-RADS 3 on DBT DBT: Additional imaging recommendation is defined as having either call back or STFU For AB-MR: Ab-MR: Call back does not apply to AB-MR and will not be evaluated Ab-MR: Short Term Follow-up (STFU) is defined as having at least one lesion rated BI-RADS 3 on AB-MR Ab-MR: Additional imaging recommendation is defined as having a STFU
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=1444 Participants
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
n=1444 Participants
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR
Call back
|
146 Participants
|
NA Participants
For AB-MR, the definition of call back does not apply.
|
—
|
—
|
|
Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR
Short-term follow-up (subject-level)
|
18 Participants
|
108 Participants
|
—
|
—
|
|
Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR
Additional imaging recommendation
|
146 Participants
|
108 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to up to 1 yearPopulation: of the 1444 women available for analysis 14 were missing reference standard information.
Reference standard positive (RS+): breast cancer (invasive or DCIS) detected on the year 0 screening or reported at any time from the year 0 to the year 1 screening. Reference standard negative (RS-): No breast cancer reported at any time from the year 0 to the year 1 screen. Incomplete: No Year 1 imaging, and \<11 months of patient follow-up (\<330 days) after year 0 screen Positive Test (T+) is defined as the imaging modality result is positive (BI-RADS 3-5), and the location of the finding is matches the location of the cancer indicated by the reference standard. Negative Test (T-) will be estimated as the fraction of reference standard negative subjects for whom the imaging modality result was negative (BI-RADS 1-2). 95% confidence intervals for the sensitivity and specificity of each modality calculated using the Wilson method.
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=1430 Participants
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
n=1430 Participants
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Prediction of Breast Cancer (Sensitivity and Specificity)
Sensitivity (T+|RS+)
|
39.1 percentage of correct classifications
Interval 22.2 to 59.2
|
95.7 percentage of correct classifications
Interval 79.0 to 99.2
|
—
|
—
|
|
Prediction of Breast Cancer (Sensitivity and Specificity)
Specificity (T-|RS-)
|
97.4 percentage of correct classifications
Interval 96.5 to 98.1
|
86.7 percentage of correct classifications
Interval 84.8 to 88.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to up to 1 yearPopulation: Participants with both DBT and MRI performed and completed PRO surveys
Testing Morbidities Index (TMI) scores \[0 (worst) to 100 (best) scale\] will be computed for abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) after the baseline screen.
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=1321 Participants
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
n=1321 Participants
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing
TMI component during exam
|
90.1 score on 0-100 scale
Interval 89.5 to 90.7
|
86.3 score on 0-100 scale
Interval 85.6 to 86.9
|
—
|
—
|
|
Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing
TMI component after exam
|
98.4 score on 0-100 scale
Interval 98.0 to 98.7
|
99.0 score on 0-100 scale
Interval 98.7 to 99.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Subjects with AB-MR, DBT and completed surveys
The proportions of participants willing to return for screening with either test, AB-MRI only, DBT only, or not willing to return for either test will be estimated.
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=1314 Participants
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
n=1313 Participants
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
n=1319 Participants
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
n=1318 Participants
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)
Screen every year
|
1107 Participants
|
1221 Participants
|
1237 Participants
|
1271 Participants
|
|
Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)
Screen every two years
|
147 Participants
|
66 Participants
|
64 Participants
|
35 Participants
|
|
Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)
Screen every four Years
|
13 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)
Never Again
|
13 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
|
Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)
Screen every three years
|
34 Participants
|
13 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPolytomous logistic regression will be used to examine factors associated with willingness to return, including screen result, cancer status, and demographic characteristics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: All subjects with DCIS detected either by AbMRI or DBT received Oncotype DX assessment
Descriptive Analyses presenting the the distributions of Oncotype-DCIS scores by modality: Ductal carcinoma in situ (DCIS) detected on abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) A low risk score is less than 39, and a high risk score is 55 or higher. A score of 39 to 54 is intermediate risk.
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=10 Participants
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
n=10 Participants
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Oncotype-DCIS Scores by Modality
Tissue not available/not submitted
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Oncotype-DCIS Scores by Modality
Low (<39)
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Oncotype-DCIS Scores by Modality
Intermediate (39-54)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Oncotype-DCIS Scores by Modality
High risk (>54)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Oncotype-DCIS Scores by Modality
DCIS not detected by Modality
|
5 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All eligible subjects who received both Ab-MR and DBT at year 0 and year 1
Breast cancer incidence will be estimated. Person-years will be measured.
Outcome measures
| Measure |
Digital Breast Tomosynthesis (DBT)
n=1291 Participants
Detection of Cancer based on results of Digital Breast Tomosynthesis (DBT) performed within 30 days following registration.
DBT and abbreviated -MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Abbreviated Breast MR (AB-MR)
Detection of Cancer based on results of abbreviated breast MR (AB-MR) performed within 30 days following registration.
DBT and AB-MR were performed on the same day and interpreted by two different radiologists, each blinded to the other modality. However, DBT and AB-MR were allowed to be performed within 24 hours of each other, as long as the radiologists remained blinded to the results of the other modality
|
Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound
Subjects with Abbreviated MRI and completed PRO surveys and their willingness to be screened in the future if AB-MRI Detects More Cancer than Mammography or Ultrasound
|
DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound
Subjects with DBT and completed PRO surveys and their willingness to be screened in the future if DBTDetects More Cancer than Mammography or Ultrasound
|
|---|---|---|---|---|
|
Incident Cancer Rate
Year 1 Screen to 12 mo post screening
|
7.89 cancers per 1,000 person-years
Interval 3.79 to 14.52
|
—
|
—
|
—
|
|
Incident Cancer Rate
12 months to 24 months post study screening
|
3.19 cancers per 1,000 person-years
Interval 0.87 to 8.18
|
—
|
—
|
—
|
|
Incident Cancer Rate
24 months to 36 months study screening
|
5.00 cancers per 1,000 person-years
Interval 1.84 to 10.89
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: end of studyPopulation: NanoString data were not collected
For all invasive cancers detected during the study period, the NanoString PAM50 will be performed. The frequencies of cancer types determined by the NanoString analysis will be tabulated and compared. For DCIS, if the Oncotype-DCIS score was performed, the distributions of scores will be tabulated and compared. All efforts to obtain NanoString data have been exhausted, therefore we have no data available to report.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious events: 6 serious events
Other events: 25 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
All Participants
n=1444 participants at risk
All participants scheduled for both DBT and AB-MR Note, because of the temporal proximity (generally the same day), it is not possible to attribute the adverse events either by arm or by an individual modality.
|
|---|---|
|
General disorders
Death NOS
|
0.21%
3/1444 • Number of events 3 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
General disorders
Disease progression
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of the right lung
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
Other adverse events
| Measure |
All Participants
n=1444 participants at risk
All participants scheduled for both DBT and AB-MR Note, because of the temporal proximity (generally the same day), it is not possible to attribute the adverse events either by arm or by an individual modality.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Eye disorders
Bilateral Eye swelling
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Gastrointestinal disorders
Nausea
|
0.14%
2/1444 • Number of events 2 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
General disorders
Facial rash
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
General disorders
Infusion site extravasation
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
General disorders
Localized edema
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
General disorders
Pain
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Immune system disorders
Allergic reaction
|
0.07%
1/1444 • Number of events 2 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Injury, poisoning and procedural complications
Bruising
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.14%
2/1444 • Number of events 2 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Nervous system disorders
Vasovagal reaction
|
0.14%
2/1444 • Number of events 2 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Psychiatric disorders
Anxiety
|
0.14%
2/1444 • Number of events 2 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Reproductive system and breast disorders
Breast pain
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Vascular disorders
Flushing
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
|
Vascular disorders
Hematoma
|
0.07%
1/1444 • Number of events 1 • 1 year for Adverse Events and All deaths while on-study
Serious Adverse Events (SAE), in addition to the standard definition include: All Grade 5 events occurring within 30 days of imaging, regardless of attribution or unexpectedness All Grade 4 events occurring within 30 days of imaging that are unexpected and have an attribution of "Possible, Probable, Definite" All Grade 4 kidney adverse events All occurrences of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) All Grade 5 events while on study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place