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Updates from RSNA

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SBI Announcements
Congratulations to DBI’s MAB member Dr Paula Gordon for the SBI Gold Medal recognition for her outstanding contributions to breast imaging, and to JoAnn Pushkin for being named 2025 SBI Honorary Fellow!

Abstracts
Prevalence screening results from the randomized UK BRAID trial were presented by Dr. Fiona Gilbert at RSNA 2024.  More than 9000 women with dense breasts and negative 2D mammogram aged 50-70 years were randomized to one of four screening groups (over 2000 women in each group): supplemental screening with abbreviated MRI (Ab-MRI), automated whole breast ultrasound (ABUS), contrast-enhanced mammography (CEM), or standard of care (no supplemental screening).

  • Cancer detection rates and recall rates were higher for CEM and Ab-MRI than ABUS, but all modalities significantly increased cancer detection1
  • Among those women invited to supplemental screening, participation rates were highest among women invited to have ABUS2
  • All cancers detected were small, but cancers seen with contrast methods were smaller3
  • All cancers detected by ABUS were invasive, as were 82% and 86% detected by CEM and Ab-MRI, respectively

 Supplemental screening in women with dense breasts results in earlier detection, with Ab-MRI and CEM finding more cancers than ABUS with higher recall rates.

 1 Cancer detection rates and recall rates for Ab-MRI, ABUS, and CEM were 17.4/1000, 4.2/1000, and 19.2/1000, respectively and 9.7%, 4.0%, and 9.7%, respectively.

2 Approximately 95.5% of invited women completed ABUS vs. 91.8% Ab-MRI and 91.1% CEM.

3 Median invasive cancer size for Ab-MRI, ABUS, and CEM respectively was 10 mm (IQR: 8-15 mm), 22 mm (IQR: 14 – 35 mm) and 11 mm (7 – 15 mm).

 Results of another study presented at RSNA 2024 by Annie Ng, Ph.D., from Kheiron Medical Technologies (now Deep Health), London, UK, found that a 2D-mammographic AI system identified more cancers than a human reader in dense breasts. The retrospective study compared sensitivity of the commercially available Mia AI system to the first human reader in double reading among 306,839 cases from over 236,739 women between 2017-2021. 

  • Sensitivity of AI was significantly greater than the human reader in women with dense breasts, whereas there was no statistical difference among women with non-dense breasts1
  • These results were maintained when analyzed by age in women aged 49-55 years or 56-71 years, respectively

 AI as a second reader has the potential to increase cancer detection in women with dense breasts compared to human readers alone.

State Insurance Law, RANZCR Statement, New Study

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State Insurance Law
A new Massachusetts insurance law requiring no-cost coverage for screening and diagnostic imaging (exemptions apply) will go into effect on 1/1/2026. For more details, see DBI’s State Law Insurance Map and Table.

RANZCR Position Statement
The Royal Australian and New Zealand College of Radiologists have issued an updated Breast Density Position Statement – Why Reporting Matters.  According to the statement, “RANZCR supports the inclusion of breast density reporting in all mammographic assessments. This move aligns with the growing global recognition of the importance of breast density in breast cancer screening. In countries like the USA, it is already mandatory to report breast density in mammograms, and similar practices are being considered in Europe.”

New Study
A study by Gjesvik and colleagues examined whether a commercially available AI algorithm for breast cancer detection could also estimate risk for future breast cancer development. This retrospective cohort study included 116,495 women aged 50-69 years who underwent at least 3 consecutive biennial mammography screening rounds in Norway. The study found that the AI algorithm for cancer detection was able to estimate future breast cancer risk 4-6 years before diagnosis. Specifically, compared to women who did not develop breast cancer,1 the study found:

  • The mean absolute difference in AI scores between breasts of women who developed screen-detected cancer or interval cancer was greater at each round and increased over the three rounds.2,3

These results suggest that AI scores for cancer detection may be used to identify women at high risk of developing cancer who may benefit from supplemental screening.

1A cancer detection score of 0-100 was given to each breast. The mean (SD) absolute differences in AI scores between breasts of women who did not develop breast cancer were  9.9 (17.5),  9.6 (17.4), and 9.3 (17.3) at the first, second, and third screening rounds, respectively.

2Scores were higher in breasts that developed cancer, and this was compared to the noncancerous breast. The mean (SD) absolute differences in AI scores between breasts of women who developed screen-detected cancer in one breast and not the other were 21.3 (28.1), 30.7 (32.5), and 79 (28.9) at the first, second, and third screening rounds, respectively.

3The mean (SD) absolute differences in AI scores between breasts of women who developed interval cancer in one breast and not the other were 19.7 (27.0), 21.0 (27.7), and 34.0 (33.6) at the first, second, and third screening rounds, respectively.

Patient Fact Sheet, New Study

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Our popular and printable dense breast Patient Fact Sheet, already translated into 25+ languages, is now available in Albanian. We extend our thanks to DBI/Europe Education Supporter Dr. Iris Allajbeu for the translation assistance!

New Study
A recent study by DBI Medical Advisory Board member Jean Seely, MD and colleagues assessed differences in breast cancer incidence, mortality, stage, and molecular subtypes by race/ethnicity among women aged 20 and older in Canada. The analysis of linked Canadian Cancer Registry (CCR) and census data found that compared to white women, women from other race/ethnicity groups:

  • Had earlier peak age at diagnosis
  • Were more likely to have a more advanced stage at diagnosis
  • Were more likely to have molecular subtypes with poorer outcomes

In addition, compared to white women, black and indigenous women had higher breast cancer mortality. These data suggest race/ethnicity-based health care inequities that should be considered in Canadian Breast cancer screening and health care policies.

Mammo Screening Guideline Comparison Table, Silver Medal of Honor, New Studies

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Comparison In Average Risk Women
This popular DBI table just updated to include the new ACOG recommendation that mammograms begin at age 40. Visit the table for comparative mammography recommendations by organization on recommended age to start, stop, and frequency.

Congratulations!
On October 24, 2024, Dr. Wendie Berg, Chief Scientific Advisor to DenseBreast-info.org, received the prestigious Silver Medal of Honor from the Austrian Medical Society to recognize her contributions to the design of the Austrian Breast Cancer Screening Program (which includes screening ultrasound for women with dense breasts).

New Studies:

-Breast Density and Sensitivity of Digital Mammography
Consistent with many prior analyses, Payne et al reported in a single-center UK study that digital mammography sensitivity decreases with increasing breast density as assessed by Volpara software, at 75% for grade a, 74% for grade b, 60% for grade c, and 51% for grade d.  Symptomatic interval cancer rates at three years increased from 1.8 per 1000 for grade a to 3.2, 5.7, and 7.9 per 1000 for density grades b, c, and d, respectively.

-CEM for Breast Screening
A retrospective, single-institution study by Sorin et al. from Tel-Aviv University evaluated performance of CEM for breast cancer screening over a 10-year period in 5,424 women at intermediate or high risk for breast cancer (15-20% lifetime risk and >20% lifetime risk, respectively), with the following results:

  • Most women (85%) included had dense breasts
  • Contrast enhancement increased cancer detection compared to the low-energy images (which are similar to a standard 2D mammogram)1,2
  • Specificity for CEM increased from the first to the third screening round, likely due to familiarity with the modality and availability of prior exams for comparison3

This study supports the viability of CEM as an effective screening modality for women with dense breasts and/or at intermediate breast cancer risk, and for high-risk women for whom MRI is not possible.

1Sensitivity for contrast-enhanced CEM images was 96% (71/74) compared to 58% (43/74) for low-energy images alone.  

2The added cancer detection rate for CEM compared to the low energy images was 5.2 per 1000 screens (13.1/1000 for CEM vs. 7.9/1000 for the low energy images).

3Specificity overall was 81.8% (4378/5350); patient-level analysis showed improvement from 79.2% (2717/3431) in the first round to 89.2% (412/462) in subsequent rounds.

Inform and Insurance Law Maps

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NEW! Now that the FDA dense breast reporting standard is in effect, DBI has retired its “State Inform Law Map” (however, the map is still available upon request).

 As the next focus is insurance coverage for supplemental screening, DBI has launched a new interactive State Law Insurance Map. The map tracks breast imaging insurance coverage by state, and a corresponding State Law Insurance Table is also available.

Visit the ”Insurance/Inform Laws” tab for individual links to:

Risk Model Tutorial / New Study

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Risk Model Tutorial
A resource reminder! DBI’s Risk Model Tutorial content for health care providers includes:

  • How the models are used
  • Risk model explanations
  • Diagnostic considerations
  • Risk models table (with live links)

 

New Study
At Rush University affiliated centers in Chicago, a retrospective review of automated breast ultrasound (ABUS) use in women with dense breasts showed the following:

  • Use of ABUS was greater in white women than in other racial or ethnic groups.1
  • Adding ABUS for women with dense breasts (both screening and diagnostic populations) increased early-stage breast cancer detection.2
  • Added false positives were not detailed.

1From September 2017 to December 2022, across 51,086 screening or diagnostic mammogram exams, 24,637 (48%) women had dense breasts and were recommended for ABUS, and 9865/24,637 (40%) had at least one ABUS examination.  Of 10,667 white women, 4943 (46%) had at least one ABUS exam, versus 2604/6843 (38%) Black, 1466/4278 (34%) Hispanic women, and 521/1590 (33%) Asian women.

2Among 9865 women who had at least one ABUS exam, 37 were found to have breast cancer, with 33/37 (89%) of those stage 0 or stage I and all node negative. The added cancer detection for ABUS was estimated at 2.4/1000 ABUS exams (the number of ABUS exams was not given).

Flowchart Update; CEM Study

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Who Needs More Screening? Flowchart
This popular screening decision support tool for health providers has just been updated, view it HERE.

CEM Study
A retrospective, single-institution study at Memorial Sloan Kettering Cancer Center reported results of several rounds of screening contrast-enhanced mammography (CEM) in 609 women with extremely dense breasts, most of whom also had other risks for breast cancer. Compared to low-energy images (similar to a standard 2D full-field digital mammogram), contrast enhancement:

  • Increased cancer detection1
  • Decreased specificity, which improved at follow up exams when prior images were available for comparison2

As summarized in an accompanying editorial by Marc Lobbes, MD, PhD, these results support the use of CEM as a safe and effective screening tool for women with dense breasts.

1The cancer detection rate after contrast enhancement vs. low-energy images was 12.7 per 1000 (16/1264) vs. 4.0 per 1000 (5/1264) for an incremental cancer detection rate of 8.7 per 1000 screens (11/1264). The sensitivity after contrast enhancement vs. the low energy images was 88.9% (95% CI: 65.3, 98.6) vs. 27.8% (95% CI: 9.7, 53.5) (P = .003).

2The specificity after contrast enhancement vs. low-energy images was 88.9% vs. 96.2%, P < .001. Specificity at follow-up improved to 90.7% (95% CI: 88.5, 92.7; P = .01).

World Dense Breast Day SUCCESS, NY insurance law

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2024 Success Story

  1. We had participation from people in 104 (!) countries
  2. Over 16.8 million people saw/read the posts
  3. Over 51,200 people interacted with the posts by liking, or sharing


New York State Insurance Law
New York has amended its breast imaging insurance law to require certain insurance policies to allow patients additional screenings for breast cancer when the provider deems such screening is necessary under nationally recognized clinical practice guidelines. Please see DBI’s Insurance/Inform Laws tab for more details.

#WDBD, Find It Early Act, EUSOBI

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#WorldDenseBreastDay Analytics
While still waiting for final analytics to come in for #WorldDenseBreastDay, but 2024 participation will break previous records! And, it was indeed a world event – we had participants from 70+ countries. Thank you to all that participated!

Find It Early Act
The U.S. bipartisan bill for expanded no-cost insurance coverage after a mammogram introduced in the House (HR3086) now has a Senate companion bill (S5141). Many thanks to co-sponsors Reps. Rosa DeLauro (D), Brian Fitzpatrick (R), and Sens. Amy Klobuchar (D), Roger Marshall (R). See Find It Early Act for updates and lobbying tools.

EUSOBI 2024, Oct 3-5
The European Society of Breast Imaging Annual Scientific Meeting takes place 3 – 5 October in Lisbon. The DenseBreast-info.org/Europe exhibition stand will be located at R4.  Please Visit! Cheryl Cruwys, DBI’s European Education Coordinator, will be there, and Executive Director JoAnn Pushkin will be at the booth on Friday the 4th.

FDA “dense breast” reporting rule

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This week’s news of the FDA effective date for density reporting resulted in much media interest and a very busy week for us. Below is a sample of some of the major stories (and more scheduled):

Alaska insurance law, National density inform

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State Insurance Law
Alaska is the latest state to enact a law that requires insurers to cover expanded breast imaging. Visit the DBI Insurance/Inform Laws tab for updated maps and new insurance table.

National Density Inform Standard (finally)
On Tuesday, September 10, the FDA’s requirement to provide patients with one of two standardized letters (“dense” or “not dense”) after their mammograms goes into effect. More information, including how to contact the FDA with questions, is available HERE.

FDA Rule, European Supporter, New Study

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FDA Reporting Standard
We are 10 days away from the FDA’s effective date for mandatory density reporting to both patients and referring providers. Please visit DBI’s FDA page which now includes a link to an FDA Compliance Guide (with helpful Q+As). DBI public comments on the September 10th effective date are available HERE.

New European Education Supporter, Albania
We welcome, Iris Allajbeu, MD, PhD, FRCR to the DBI/Europe team! Dr. Allajbeu is Associate Professor of Radiology, Western Balkans University, Tirana, as well as honorary consultant radiologist for the American Hospital in Tirana, International Advisory Board for the Western Balkans University, honorary clinical lecturer and co-lead of Clinical Research, President of ALSOBI and Vice President of the AAR. She is also Senior Clinical Research Associate, Honorary Consultant, Department of Radiology, University of Cambridge Addenbrooke’s Hospital, Cambridge, UK.

Study: Geographic Accessibility
Christensen et al. considered access to MRI and mammography by examining zip codes and a mapping tool that displays the relative socioeconomic conditions of neighborhoods. The study found the average distance to access breast MRI was 23 miles, 22 miles for breast ultrasound, and only 8 miles for mammography.

  • Distances were greater in lower socioeconomic areas and rural zip codes.
  • Contrast-enhanced mammography can be implemented on most existing digital mammography equipment and could improve access to supplemental screening.

State Insurance Law; AbMRI research

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State Insurance Law Amendment
Illinois has amended its insurance law for expanded breast imaging.  MBI will now be included (effective 1/1/26), please see DBI’s legislation MAP for details.

Research Analysis
An analysis of “real-world” experience with supplemental abbreviated MRI (AB-MRI) screening in women with dense breasts and average breast cancer risk was conducted by senior author and DBI Advisory Board Member Emily Conant, MD and colleagues. The cancer detection rate for baseline AB-MRI exams was higher than for subsequent exams, however the difference was not significant. [1]

  • As expected, for exams with one-year follow-up, the false-positive rate decreased with subsequent exams compared to baseline exams. [2]
  • All cancers detected with baseline or subsequent AB-MRI exams were stage 0 or 1, and there were no symptomatic interval cancers.
  • The results support the effectiveness AB-MRI for supplemental screening in women with dense breasts at otherwise average breast cancer risk and suggest that adding screening MRI every two years may be sufficient, though further study is warranted.

1. The cancer detection rate for baseline vs. subsequent AB-MRI exams was 18.9 per 1000 (38/2007) vs. 12.1per 1000 (7/278) respectively (P=.37).
2. The false positive rate decreased from 7.7% (116/1497) for baseline exams to 2.8% (10/359) for subsequent exams (P<.001).

World Dense Breast Day; Screening Ultrasound Study

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World Dense Breast Day
A reminder that World Dense Breast Day will take place on September 25th! The purpose of this worldwide one-day social media blitz is to raise awareness about dense breasts and share medically-sourced information for women and health providers. To educate in every time zone, DBI will be launching 100+ social media posts in a single 24-hour period, including a campaign in Spanish.  Please join us! Show your support of education on the topic by following/sharing the full day’s #WorldDenseBreastDay social media posts.

2023 WDBD Success Story:

• Participation from people in 64 countries

• Over 12.3 million people saw/read the posts

• Over 28,500 people interacted with the posts by clicking, liking, or sharing


Study Analysis / Screening Ultrasound
Analysis of Breast Cancer Surveillance Consortium results by Sprague and colleagues in over 26,000 women with dense breasts found that adding screening ultrasound to mammography detected 2 cancers/1000 women screened overall (95%CI 1.6, 2.4).  There was greater benefit, with both a higher cancer detection rate and higher positive predictive value of biopsy, in women with high vs. low/average 6-year risk of advanced breast cancer (BCSC model):

  • Cancer detection rate for high vs. low/average 6-year advanced breast cancer risk: [5.5 (95% CI 3.5, 8.6) vs. 1.3 (95% CI 1.0, 1.8) per 1000 exams]
  • Positive predictive value of biopsy for high vs. low/average 6-year advanced breast cancer risk: [15.0% (95% CI 9.9, 22.2) vs 4.9% (95% CI 3.3, 7.2)]

Of 68 cancers found by screening US, 55 (81%) were invasive and 39/46 (85%) with nodal staging were node negative.

Research Round Up

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AI vs. ultrasound
A single-institution, retrospective study of 5707 women with dense breasts and a negative mammogram at Seoul National University Hospital found that adding artificial intelligence (AI) is less effective than adding screening ultrasound (US). Supplemental physician-performed whole breast handheld US found more cancers than 2D digital mammography (MG) plus AI with an added incremental cancer detection rate of 2.2 (95% CI 1.1, 3.8) per 1000 screens. All 12 additional cancers seen by US alone were invasive and node negative. While sensitivity was higher for MG plus US than for MG plus AI  (97% vs. 60%, p=.002), specificity was lower (77.6% vs. 95.3%, p<.001). Further research is needed to better understand the role of AI in women with dense breasts.

Contrast-enhanced mammography
Patel and colleagues at Mayo Clinic, Scottsdale, AZ, reported results of the first round of screening contrast-enhanced mammography (CEM) after negative digital breast tomosynthesis (DBT) in 460 women at elevated risk, of whom 408 (89%) had dense breasts. CEM prompted biopsy in 37 (8.0%) women, with 11/37 (30%) found to have cancer, for a supplemental cancer detection rate of 24/1000. Specificity of CEM was 393/449 (87.5%). Of 14 total malignancies found, 10 were invasive, median size 9 mm, all node negative; there was one interval cancer found on screening MRI.

NEW Technology Tab Table

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New – updated table for health professionals, Cancer Detection by Screening Method in Dense Breasts. By modality, the table shows results of supplemental screening after mammography in dense breasts in first and subsequent rounds of screening. It includes the added cancer detection benefit, change in false positive recall rate, and availability.

As a reminder, patient content on the topic is also available in DBI’s new very popular page Screening Tests After a Mammogram.