Asymptomatic
Conditions
Brief summary
This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes. These pictures can show the difference between normal and diseased tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening with abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen women with dense breasts.
Detailed description
PRIMARY OBJECTIVES: I. To compare the rates of detection of invasive cancers between the initial abbreviated breast (AB)-magnetic resonance (MR) and digital tomosynthesis mammography (DBT). SECONDARY OBJECTIVES: I. To compare the positive predictive value (PPV) of biopsies, call back rates, and short-term follow up rates after AB-MR and DBT on both the initial and 1 year follow up studies. II. To estimate and compare the sensitivity and specificity of AB-MR and DBT, using the 1 year follow up to define a reference standard. III. To compare patient-reported short-term quality of life related to diagnostic testing with AB-MR and DBT using the Testing Morbidities Index. IV. To compare willingness to return for testing with AB-MRI versus (vs) DBT within the recommended screening interval and explore factors associated with willingness to return for screening. V. To compare the tumor biologies of invasive cancers and ductal carcinoma in situ (DCIS) detected on AB-MR and DBT. VI. To estimate the incident cancer rate during 3 years following the year-1 AB-MR/DBT when patients return to standard screening. OUTLINE: Participants are randomized to 1 of 2 arms. 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. 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. After completion of study, patients are followed up at every 6 months for 3 years.
Interventions
DIAGNOSTIC_TESTContrast-enhanced Magnetic Resonance Imaging
Undergo AB-MR
DIAGNOSTIC_TESTDigital Tomosynthesis Mammography
Undergo DBT
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patents must be scheduled for routine screening DBT * Women must not be pregnant or breast-feeding; all females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the year 1 AB-MR and DBT studies are performed * Patient?s breast density must be known; patients must have mammographically dense breasts, American College of Radiology \[ACR\] Breast Imaging \[BI\]- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening * Patient must be asymptomatic for breast disease and undergoing routine screening * Patient must have no known breast cancer (DCIS or invasive cancer), not currently undergoing treatment for breast cancer, or planning surgery for a high risk lesion (atypical ductal breast hyperplasia \[ADH\], atypical lobular breast hyperplasia \[ALH\], lobular breast carcinoma in situ \[LCIS\], papilloma, radial scar) * Patient must not be taking chemoprevention for breast cancer * Patient must not have undergone breast ultrasound within 12 months prior to randomization * Patient must not have previously had a breast MRI * Patient must not have previously had molecular breast imaging (MBI, multiplexed ion beam imaging \[MIBI\]) * Patient must agree to not undergo screening ultrasound (of breast) for the duration of the 1 year study period * Patient must not be suspected of being at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of \>= 20-25%) * Patient must be able to undergo breast MRI with contrast enhancement; patients unable to undergo breast MRI with contrast enhancement for any reason are ineligible * No history of untreatable claustrophobia * No presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication * No history of sickle cell disease * No contraindication to intravenous contrast administration * No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance * No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice * Weight less than or equal to the MRI table limit * No women who have had prior contrast enhanced mammography (contrast enhanced spectral mammography \[CESM\] or contrast enhanced digital mammography \[CEDM\]) * No women who have breast prosthetic implants (silicone or saline)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screen-detected Invasive Cancer Verified by Pathology | Up to 1 year | 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 (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) of Biopsies | Baseline to up to 1 year | 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 |
| Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR | Baseline | For 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 |
| Prediction of Breast Cancer (Sensitivity and Specificity) | Baseline to up to 1 year | 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. |
| Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing | Baseline to up to 1 year | 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. |
| Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Up to 1 year | 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. |
| Factors Associated With Willingness to Return for Screening | Up to 1 year | Polytomous logistic regression will be used to examine factors associated with willingness to return, including screen result, cancer status, and demographic characteristics. |
| Oncotype-DCIS Scores by Modality | Up to 1 year | 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. |
| Incident Cancer Rate | Up to 3 years | Breast cancer incidence will be estimated. Person-years will be measured. |
| NanoString Tumor Biologies of Invasive Cancers and Ductal Carcinoma in Situ (DCIS) Detected on AB-MR and DBT | end of study | 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. |
Countries
Germany, United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Comstock
ECOG-ACRIN Cancer Research Group
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 757 |
| 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 | 759 |
| Total | 1,516 |
Baseline characteristics
| Characteristic | Total | Arm B (AB-MR, DBT) | Arm A (DBT, AB-MR) |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 8.6 | 54.9 years STANDARD_DEVIATION 8.4 | 54.9 years STANDARD_DEVIATION 8.7 |
| Breast density (baseline DBT) Almost entirely fat | 2 Participants | 1 Participants | 1 Participants |
| Breast density (baseline DBT) Extremely dense | 222 Participants | 109 Participants | 113 Participants |
| Breast density (baseline DBT) Heterogeneously dense | 1128 Participants | 564 Participants | 564 Participants |
| Breast density (baseline DBT) Scan not performed | 48 Participants | 19 Participants | 29 Participants |
| Breast density (baseline DBT) Scattered fibroglandular densities | 116 Participants | 66 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 31 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1382 Participants | 678 Participants | 704 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 92 Participants | 50 Participants | 42 Participants |
| Menopausal Status Naturally post-menopausal | 671 Participants | 355 Participants | 316 Participants |
| Menopausal Status Peri-menopausal | 94 Participants | 45 Participants | 49 Participants |
| Menopausal Status Pre-menopausal | 442 Participants | 206 Participants | 236 Participants |
| Menopausal Status Surgically post-menopausal | 243 Participants | 129 Participants | 114 Participants |
| Menopausal Status Unknown (data not available) | 66 Participants | 24 Participants | 42 Participants |
| Prior personal history of breast cancer No | 1452 Participants | 728 Participants | 724 Participants |
| Prior personal history of breast cancer Unknown | 55 Participants | 25 Participants | 30 Participants |
| Prior personal history of breast cancer Yes | 9 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 60 Participants | 22 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 70 Participants | 41 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 94 Participants | 53 Participants | 41 Participants |
| Race (NIH/OMB) White | 1287 Participants | 639 Participants | 648 Participants |
| Sex/Gender, Customized Female | 1516 Participants | 759 Participants | 757 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 1,444 |
| other Total, other adverse events | 25 / 1,444 |
| serious Total, serious adverse events | 6 / 1,444 |
Outcome results
Primary
Screen-detected Invasive Cancer Verified by Pathology
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 (%).
Time frame: Up to 1 year
Population: Subjects with both DBT and AB-MR
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Screen-detected Invasive Cancer Verified by Pathology | No Invasive Cancer Detected | 1437 Participants |
| Digital Breast Tomosynthesis (DBT) | Screen-detected Invasive Cancer Verified by Pathology | Invasive Cancer Detected | 7 Participants |
| Abbreviated Breast MR (AB-MR) | Screen-detected Invasive Cancer Verified by Pathology | No Invasive Cancer Detected | 1427 Participants |
| Abbreviated Breast MR (AB-MR) | Screen-detected Invasive Cancer Verified by Pathology | Invasive Cancer Detected | 17 Participants |
Comparison: The proportion of participants who had an invasive cancer, verified by pathology, detected by each modality (the invasive cancer detection rates) will be made using exact McNemar's test.p-value: 0.00295% CI: [0.0022, 0.0116]McNemar
Secondary
Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR
For 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
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR | Call back | 146 Participants |
| Digital Breast Tomosynthesis (DBT) | Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR | Short-term follow-up (subject-level) | 18 Participants |
| Digital Breast Tomosynthesis (DBT) | Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR | Additional imaging recommendation | 146 Participants |
| Abbreviated Breast MR (AB-MR) | Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR | Call back | NA Participants |
| Abbreviated Breast MR (AB-MR) | Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR | Short-term follow-up (subject-level) | 108 Participants |
| Abbreviated Breast MR (AB-MR) | Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR | Additional imaging recommendation | 108 Participants |
Comparison: The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR short term follow-up ratesp-value: <0.0001McNemar
Comparison: The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR additional imaging ratesp-value: 0.02McNemar
Secondary
Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing
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.
Time frame: Baseline to up to 1 year
Population: Participants with both DBT and MRI performed and completed PRO surveys
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing | TMI component during exam | 90.1 score on 0-100 scale |
| Digital Breast Tomosynthesis (DBT) | Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing | TMI component after exam | 98.4 score on 0-100 scale |
| Abbreviated Breast MR (AB-MR) | Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing | TMI component during exam | 86.3 score on 0-100 scale |
| Abbreviated Breast MR (AB-MR) | Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing | TMI component after exam | 99.0 score on 0-100 scale |
Secondary
Factors Associated With Willingness to Return for Screening
Polytomous logistic regression will be used to examine factors associated with willingness to return, including screen result, cancer status, and demographic characteristics.
Time frame: Up to 1 year
Secondary
Incident Cancer Rate
Breast cancer incidence will be estimated. Person-years will be measured.
Time frame: Up to 3 years
Population: All eligible subjects who received both Ab-MR and DBT at year 0 and year 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Incident Cancer Rate | Year 1 Screen to 12 mo post screening | 7.89 cancers per 1,000 person-years |
| Digital Breast Tomosynthesis (DBT) | Incident Cancer Rate | 12 months to 24 months post study screening | 3.19 cancers per 1,000 person-years |
| Digital Breast Tomosynthesis (DBT) | Incident Cancer Rate | 24 months to 36 months study screening | 5.00 cancers per 1,000 person-years |
Secondary
NanoString Tumor Biologies of Invasive Cancers and Ductal Carcinoma in Situ (DCIS) Detected on AB-MR and DBT
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.
Time frame: end of study
Population: NanoString data were not collected
Secondary
Oncotype-DCIS Scores by Modality
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.
Time frame: Up to 1 year
Population: All subjects with DCIS detected either by AbMRI or DBT received Oncotype DX assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Oncotype-DCIS Scores by Modality | Tissue not available/not submitted | 4 Participants |
| Digital Breast Tomosynthesis (DBT) | Oncotype-DCIS Scores by Modality | High risk (>54) | 0 Participants |
| Digital Breast Tomosynthesis (DBT) | Oncotype-DCIS Scores by Modality | Low (<39) | 1 Participants |
| Digital Breast Tomosynthesis (DBT) | Oncotype-DCIS Scores by Modality | Intermediate (39-54) | 0 Participants |
| Digital Breast Tomosynthesis (DBT) | Oncotype-DCIS Scores by Modality | DCIS not detected by Modality | 5 Participants |
| Abbreviated Breast MR (AB-MR) | Oncotype-DCIS Scores by Modality | DCIS not detected by Modality | 4 Participants |
| Abbreviated Breast MR (AB-MR) | Oncotype-DCIS Scores by Modality | Intermediate (39-54) | 1 Participants |
| Abbreviated Breast MR (AB-MR) | Oncotype-DCIS Scores by Modality | High risk (>54) | 0 Participants |
| Abbreviated Breast MR (AB-MR) | Oncotype-DCIS Scores by Modality | Tissue not available/not submitted | 3 Participants |
| Abbreviated Breast MR (AB-MR) | Oncotype-DCIS Scores by Modality | Low (<39) | 2 Participants |
Secondary
Positive Predictive Value (PPV) of Biopsies
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
Time frame: Baseline to up to 1 year
Population: 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+)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Positive Predictive Value (PPV) of Biopsies | 31.0 percentage of Biopsy Recommended |
| Abbreviated Breast MR (AB-MR) | Positive Predictive Value (PPV) of Biopsies | 19.6 percentage of Biopsy Recommended |
Comparison: Positive Predictive Value (PPV)p-value: 0.15Leisenring
Secondary
Prediction of Breast Cancer (Sensitivity and Specificity)
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.
Time frame: Baseline to up to 1 year
Population: of the 1444 women available for analysis 14 were missing reference standard information.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Prediction of Breast Cancer (Sensitivity and Specificity) | Sensitivity (T+|RS+) | 39.1 percentage of correct classifications |
| Digital Breast Tomosynthesis (DBT) | Prediction of Breast Cancer (Sensitivity and Specificity) | Specificity (T-|RS-) | 97.4 percentage of correct classifications |
| Abbreviated Breast MR (AB-MR) | Prediction of Breast Cancer (Sensitivity and Specificity) | Sensitivity (T+|RS+) | 95.7 percentage of correct classifications |
| Abbreviated Breast MR (AB-MR) | Prediction of Breast Cancer (Sensitivity and Specificity) | Specificity (T-|RS-) | 86.7 percentage of correct classifications |
p-value: 0.001McNemar
p-value: <0.001McNemar
Secondary
Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)
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.
Time frame: Up to 1 year
Population: Subjects with AB-MR, DBT and completed surveys
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every four Years | 13 Participants |
| Digital Breast Tomosynthesis (DBT) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every two years | 147 Participants |
| Digital Breast Tomosynthesis (DBT) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Never Again | 13 Participants |
| Digital Breast Tomosynthesis (DBT) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every three years | 34 Participants |
| Digital Breast Tomosynthesis (DBT) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every year | 1107 Participants |
| Abbreviated Breast MR (AB-MR) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every three years | 13 Participants |
| Abbreviated Breast MR (AB-MR) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every four Years | 5 Participants |
| Abbreviated Breast MR (AB-MR) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Never Again | 8 Participants |
| Abbreviated Breast MR (AB-MR) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every two years | 66 Participants |
| Abbreviated Breast MR (AB-MR) | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every year | 1221 Participants |
| Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every three years | 7 Participants |
| Ab-MRI Future Screen if AB-MRI Detects 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 | 1237 Participants |
| Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every two years | 64 Participants |
| Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every four Years | 4 Participants |
| Ab-MRI Future Screen if AB-MRI Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Never Again | 7 Participants |
| DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every four Years | 4 Participants |
| DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every two years | 35 Participants |
| DBT Future Screen if DBT Detects 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 | 1271 Participants |
| DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Screen every three years | 3 Participants |
| DBT Future Screen if DBT Detects More Cancer Than Mammography or Ultrasound | Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT) | Never Again | 5 Participants |