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BI-RADS: The Next Edition

American College of Radiology®

BI-RADS Committee Chairs


Mary S. Newell, MD- BI-RADS Committee Chair
Stamatia Destounis, MD- Mammography Sub-Chair
Jessica Leung, MD- Ultrasound Sub-Chair
Wendy DeMartini, MD- MRI Sub-Chair
Peter Eby, MD- Audit and Outcomes Monitoring Sub-Chair

© 2021 American College of Radiology® | All rights reserved.


Disclosures
• Mimi Newell- none
• Stamatia Destounis
• iCAD Advisory Board
• Hologic Inc. Research study EWBC
• Jessica Leung-
• Wendy DeMartini-
• •Kheiron Medical Technologies: Advisory Board
• •Whiterabbit.ai: Grant Support
• Peter Eby- none
Update overview
• General comments
• Sub-committee specific predicted updates—
• Still in review process
Update overview
• Everything on the table
• Evidence, expert consensus, common sense
• Not that much to change!
• Many-eyes review process
• Sub-committee, sub chairs, full committee, stakeholder groups
• Format: looking at publishing hosts
• Optimize ease of search and updating (…..v6.2)
• Highlight new content
Structured Clinical Indications
(modality-neutral)
Major Indication Optional Subcategory Relevant History to
Indication Report, if Known
Asymptomatic • Elevated Risk • Gene mutation
Screening • Dense Breasts • Estimated cancer
• Completed treatment for breast cancer risk
• Other
Diagnostic: Work- • Clinical Findings • Clinical finding type
Up • Imaging Findings • Imaging finding type
• Follow-up Category 3
• Follow-up after Biopsy
• Implant Assessment
• Other

Diagnostic: • Extent of Disease Before Definitive Surgery • Location and size of


Current Breast • Response During or After Neoadjuvant Therapy cancer on prior
Cancer • Other imaging evaluation
Structured Clinical Indications
(modality-neutral)
• Vendor-templated/structured reporting
• Coding/billing implications (positive)
• Method of detection implications
• Modality plus indication
• Example:
• Diagnostic exam
• Clinical finding
• Nipple discharge
• MRI
Structured Clinical Indications
(modality-neutral)

• Research/outcomes/benchmarks
• Starts: “Diagnostic: Current Breast Cancer (response to treatment)”;
ends as B4/5
• Starts: “Follow-up Category 3”; ends as B4…or B2
• More detail, better data
Update overview
• Expected release: 2023
American College of Radiology®

Mammography BI-RADS Update


Chair-Stamatia Destounis, MD
Sally Friedewald, MD
Lars Grimm, MD
Steve Poplack, MD
Janice Sung, MD

© 2021 American College of Radiology® | All rights reserved.


Introduction
• The lexicon and illustrations have been updated and expanded
with examples primarily from digital mammography (DM),
including digital breast tomosynthesis (DBT) and synthetic
mammogram images (SM)

• Captions include in capital letters the dominant findings and in many cases
additional descriptors in small letters
• Pathology included where available
• Management based on most suspicious feature
Digital Breast Tomosynthesis
The Guidance chapter first introduced in the Fourth
edition in response to many questions and
suggestions concerning terminology and auditing

• The goal of this chapter is to help the interpreting radiologist with


the management of certain scenarios and imaging findings that
occur in the clinical setting in an effort to improve consistency
across breast imaging practices
• This chapter has been updated to incorporate new
frequently asked questions, particularly with the recent adoption
of DBT
Digital Breast Tomosynthesis
• The definition of screening and diagnostic examinations edited
to include DBT and its benefits of lower recall rate and higher
cancer detection
• Added that DBT also allows better visualization of a lesion’s
margins and improves the ability to localize lesions within
the breast
• even when a lesion is seen in only one standard
mammographic projection
• And, increased conspicuity and localization of lesions with
DBT may preclude the need for additional
diagnostic mammographic views
Breast Density
• In the BI-RADS® 5th edition (2013), the classification of breast density
transitioned from an evaluation of the percentage of dense tissue to an
assessment based on the likelihood that overlying tissue may obscure a
cancer
• This classification continues in the 6th edition. If the breast tissue in
any region is dense and potentially masking an underlying cancer, then the
breast density classification should be based on an assessment of the
densest region and not the entire breast
Breast Density
There are four categories of breast density which we
simplified the wording:
• almost entirely fatty
• scattered tissue
• heterogeneously dense
• and extremely dense
Breast Density

• Similarly, if each breast falls into different density categories, then


the greater density of the two is assigned to that examination
• Breast density is assigned to each examination to accurately
reflect the current breast density and is updated each time the
patient has a mammogram
Breast Density
Breast density is significant for two reasons: mammographic accuracy and
breast cancer risk
• Impact of breast density on mammographic accuracy is due to the masking
effect of dense fibroglandular tissue and in this context, it is felt to be
perhaps more significant than inherent risk
• Similar to increasing age, genetic mutation, family history, and reproductive
history, having dense breasts confers an increased inherent risk for
developing breast cancer
• Compared to the breasts of women with scattered areas of fibroglandular
tissue, the odds ratio of breast cancer is 0.6 for almost entirely fatty, 1.4 for
heterogeneously dense, and 1.6 for extremely dense breasts
Typically benign calcifications
• The term "Popcorn-like" calcifications have been removed and replaced by
coarse
• Coarse calcifications may be produced by an involuting fibroadenoma and
over time may coalesce to become a single very large calcification. An
involuting fibroadenoma may be associated with a mass or calcification

• There may be some overlap in the appearance of the typically benign


descriptor coarse and the suspicious descriptor coarse heterogeneous, but
coarse calcifications are typically larger with smoother margins
Typically benign calcifications
• The term “punctate”, historically a subset of round calcifications
when <0.5 mm in size has been removed, given the impracticality
of measuring the size of individual calcifications

• Now these calcifications reside under the round calcification


descriptor
Typically benign calcifications

• Layering (historically called “milk of calcium”)

• Layering calcifications are semilunar, crescent shaped, curvilinear (concave


up), or linear on mediolateral oblique (MLO) or 90° lateral (LM/ML) views

• On craniocaudal (CC) views they are often less evident and appear as
round, smudgy deposits
Solitary Dilated Duct

• In the 5th edition, it was endorsed that tissue diagnosis be recommended


for a solitary dilated duct unless a benign etiology was demonstrated

• Newer literature confirms prior research that a solitary dilated duct is a


rare finding and, when not associated with suspicious imaging features
such as an associated mass, architectural distortion, or microcalcifications
Solitary Dilated Duct

• In asymptomatic individuals it has a very low likelihood of malignancy and


can be considered benign

• If a solitary dilated duct is present in a symptomatic woman or is associated


with other suspicious imaging features, then additional imaging evaluation
leading to tissue diagnosis should be considered.
American College of Radiology®

Breast Ultrasound
Jessica W. T. Leung, MD, Chair
Jay A. Baker, MD
Regina J. Hooley, MD
Vilert A. Loving, MD
Jocelyn A. Rapelyea, MD

© 2021 American College of Radiology® | All rights reserved.


Echogenic Rind
• Introduction of new element in associated features
• Thick band of echogenic tissue surrounding all or part of a breast
mass
• Disrupts texture of normal tissue surrounding the mass
• Likely represents desmoplastic reaction or peritumoral edema
Echogenic Rind
• Distinct (and opposite) from echogenic pseudocapsule
• Uniformly thin
• Oval shape suggesting benignity

Fibroadenoma

Image Source: Jay Baker, MD (ACR BI-RADS)


Radial Antiradial
Echogenic Rind
• Distinct (and opposite) from echogenic pseudocapsule
• Uniformly thin
• Oval shape suggesting benignity
• Less sharply demarcated, thicker, more variable in thickness
• Mass of any shape
Echogenic Rind

Radial Antiradial
Invasive Ductal Carcinoma
Image Source: Jay Baker, MD (ACR BI-RADS)
Echogenic Rind
• Distinct (and opposite) from echogenic pseudocapsule
• Uniformly thin
• Oval shape suggesting benignity
• Less sharply demarcated, thicker, more variable in thickness
• Mass of any shape
• Inclusion of echogenic rind in measurement of mass
• Best correlation with histology1,2
1. Joekel J, et al. Breast Cancer Res Treat 2016; 156:311-317
2. Meier-Meitinger M, et al. Eur Radiol 2011; 21:1180-1187
Echogenic Rind
• Introduction of new element in associated features
• Thick band of echogenic tissue surrounding all or part of a breast
mass
• Disrupts texture of normal tissue surrounding the mass
• Likely represents desmoplastic reaction or peritumoral edema
• High PPV for malignancy1-3  biopsy unless proven benign
• Notable exception: fat necrosis
1. Constantini M, et al. J Ultrasound Med 2006; 25:649-659
2. Durmus T, et al. Ultraschall Med 2014; 35:547-553
3. Watanabe T, et al. J Med Ultrason 2021; 48:71-81
Echogenic Rind

Fat Necrosis
Image Source: Jay Baker, MD (ACR BI-RADS)
Given the current advances in US equipment capabilities
and knowledge of breast US, there is increasing
awareness and identification of abnormalities at US that
do not rise to the criteria of a mass.
Nonmass
• Introduction of new category of sonographic finding
• Lacks the 3-dimensionality of a mass
• Identifiable in at least 2 planes, but may be primarily visualized
in 1 plane only
• Lacks definable shape and margin for assessment
• If malignant, histology more likely to be in-situ (vs invasive)
carcinoma
Nonmass
• Echogenicity
• Hypoechoic, isoechoic, hyperechoic, mixed echogenicity
• Distribution
• Regional, focal, linear, segmental
• Shape/Margin
• Not applicable as shape/margin not characterizable
• Orientation (?)
• Parallel, antiparallel
Nonmass
• Associated imaging variables
• Echogenic rind, architectural distortion, posterior shadowing,
hypervascularity, ductal extension or abnormal ductal changes,
calcifications = suggest malignant
• Presence of small cysts suggests benign1
• Associated clinical variables
• Probability of malignancy increases in setting of nipple
discharge or palpability

1. Park KW, et al. Eur Radiol 2021; 31:1693-1706


Nonmass
• Importance of imaging correlation
• High probability of malignancy in presence of imaging correlate
at other modalities
• Architectural distortion or asymmetry at mammography
• Abnormal enhancement at contrast-enhanced
mammography or MRI
LM CC
Image Source: Jessica Leung, MD (ACR BI-RADS)
Image Source: Jessica Leung, MD (ACR BI-RADS)
Image Source: Jessica Leung, MD (ACR BI-RADS)
Ductal Carcinoma In Situ DCIS

Image Source: Jessica Leung, MD (ACR BI-RADS)


CEM DBT DBT Synthetic

Image Source: Jessica Leung, MD (ACR BI-RADS)


Complex Sclerosing Lesion
Longitudinal Transverse
Image Source: Jessica Leung, MD (ACR BI-RADS)
Lymph Nodes
Internal
• Expansion of discussion on lymph nodes Rib
Mammary
Rib
Node
• Location
• Intramammary node
• Axillary node (levels I, II, III)
• Internal mammary node Supraclavicular
Node
• Supraclavicular node
• Morphology Axillary Node with
Compressed Hilum
• Cortical-hilar relationship
American College of Radiology®

Breast MRI
Wendy DeMartini, MD, Chair
Roberta Strigel, MD, MS, Vice-Chair
Katja Pinker, MD, PhD
Habib Rahbar, MD
Lilian Wang, MD

© 2021 American College of Radiology® | All rights reserved.


Acquisition Parameters: Revised and Expanded
• Standard “full-protocol” contrast enhanced
• At least 2 post-contrast series
• Abbreviated contrast enhanced
• Shorter
• Typically < 10 minutes
• At least 1 post-contrast series
• “Faster” techniques with early high temporal series
Acquisition Parameters: Revised and Expanded
• Name of post-contrast series at 60-120
seconds changed from “initial” to “peak”
• DWI
Peak
• Compliment to DCE to help characterize Post
findings, predict and monitor response
to therapy
• Ongoing research as part of non-contrast
protocols for screening
• BI-RADS reporting guidelines not
included at this time
Focus: Removed From Lexicon
• Modern MRI techniques allow unique enhancing finding <= 5 mm
to be characterized as a small mass (meets criteria/features of a
mass) or focal NME (does not meet criteria/features of a mass)
and categorized appropriately
• Heterogeneity in use of “focus” across practices and in the
literature
• Future research should investigate the predictive morphologic
and kinetic features of such small masses and NME, optimally in
multi-site prospective studies
T2 Signal Intensity: New Descriptor for Masses
• Benign and malignant enhancing masses can be hyperintense on
bright fluid (T2) sequences
• A T2 hyperintense mass that is also oval and circumscribed and
demonstrates homogeneous internal enhancement or dark
internal septations has a low probability of malignancy <=2%
Mass T2 Signal Intensity
• Should be assessed and reported for masses that are oval and
circumscribed and demonstrate homogeneous internal
enhancement or dark internal septations
• Hyperintense
• Not hyperintense
• Assessed subjectively
• Categorized as hyperintense if it is uniformly bright throughout
the mass, and as bright as a normal-appearing lymph node
Lymph Nodes: New Separate Section
• Intramammary
• Axillary
• Internal mammary
• Normal-appearing vs. abnormal-appearing
Axillary Lymph Nodes: Abnormal-Appearing
• Subjectively asymmetric
• Compared to ipsilateral or contralateral nodes
• Cortical thickening
• > 3 mm not applicable
• No data for MRI
• Appearance of many normal nodes
• Rounding, absence of hila
• Not sole criteria
• Appearance of many small normal nodes
Subjectively Asymmetric

Cortical Effacement
thickening of hilum
Axillary Lymph Nodes: Describe Levels (I-III)
• Important anatomic staging
information
• Prognosis and management Pec Minor

Pec Minor Pec Minor


Pec Minor

Level I Level II Level III


Category 4 Subdivisions (4A-C): New for MRI
• Suggested for MG and US
• Potential benefits
• Meaningful audit
• Rad-path correlation
• Patient/provider
expectations
• MRI malignancy rates in
BI-RADS ranges for MG/US

Strigel RM, et al. American Journal of Roentgenology. 2017


Current Cancer: Category 6 vs. 4/5
Separate Additional in Ipsilateral Breast
• >= 1-2 cm from known cancer
• And/or increase extent >= 1-2 cm
• And/or significantly change clinical management

Mass =
Biopsy Proven NME
Malignancy 7 cm
American College of Radiology®

Audit and Outcomes Monitoring


Peter Eby, MD, Chair
Debbie Bennett, MD
Ethan Cohen, MD
Donna Plecha, MD
Ed Sickles, MD

© 2021 American College of Radiology® | All rights reserved.


New name!

• Follow-up and
Outcome Monitoring
New name!

• Follow-up and • Auditing and


Outcome Monitoring Outcomes Monitoring
New name!

• Follow-up and • Auditing and


Outcome Monitoring Outcomes Monitoring

Same mission:
Provide a universal recipe for practices and individuals to
evaluate, adjust and improve performance for patients.
Benchmarks Updated

Screening Diagnostic
2D Mammography ✔️ ✔️
DBT ✔️ ✔️
Ultrasound ✔️ ✔️
MRI ✔️ ✔️
Updated Table of
Screening Vs Diagnostic for Audit
Screening Audit Flowchart Example
Diagnostic Audit Flowchart Example
Adding BI-RADS 3 to Basic Audit
• New addition to the basic clinically relevant audit
• Count only initial BI-RADS 3 assessments
• Provide internal feedback for utilization and PPV
• Encourage additional collection and publication of data for US
and MRI
BI-RADS 3 Audit Flowchart Example
BWUP: Benign with Upgrade Potential
• “High risk” has a new name
• High risk histology list is updated
∙Lobular carcinoma in situ
∙Atypical ductal hyperplasia
∙Atypical lobular hyperplasia
∙Peripheral duct papilloma
∙Phyllodes tumor
∙Radial scar/Complex sclerosing lesion
∙Flat epithelial atypia
BWUP: Benign with Upgrade Potential
• “High risk” has a new name
• High risk histology list is updated
∙Lobular carcinoma in situ
∙Atypical ductal hyperplasia
∙Atypical lobular hyperplasia
∙Peripheral duct papilloma
∙Phyllodes tumor
∙Radial scar/Complex sclerosing lesion
∙Flat epithelial atypia
But wait, there’s more…
• What not to audit
• Guidance and FAQ’s

• Audit helps improve individual performance and


patient care.
• Data collection and publication to
update benchmarks and standards highly
encourage.
Your comments, questions and input are
encouraged too!

• PeterEbyMD@proton.me
Update overview
• Expected release: 2023

• BI-RADS CEM Supplement now available


• Chair-Carol Lee, MD
• Jordana Phillips, MD
• Janice S. Sung, MD
• John M. Lewin, MD
• Mary S. Newell, MD

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