Dense Breasts
A Breast Cancer Risk Factor
and Imaging Challenge
Renee Pinsky, MD University of Michigan Department of Radiology Division of Breast Imaging
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No Disclosures
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“ARE YOU DENSE?”
• QUIZ:
– a. Breast Imaging question regarding the
mammographic appearance of breast
tissue.
– b. Current legislative issue in many states.
– c. A teenager‟s disrespectful response
when you do not know how to download an
app to your smart phone.
– d. a and b
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ARE YOU DENSE?
• Nancy Capello founder
– 2004 dx‟d stage 3c breast cancer
– Normal mammogram 2 months earlier
– Found out after treatment that she
had dense breasts
– Founded organization
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• Mission Statement: „dedicated to
informing the public about dense
breast tissue and its significance for
the early detection of breast
cancer.‟
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Why are we interested?
• An average woman‟s lifetime risk
for developing breast cancer is
1: 8
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INCIDENCE
• American Cancer Society estimate
for 2012 was 229,060 new cases of
breast cancer in US
– 3/4 Invasive cancer
– 1/4 Ductal Carcinoma In Situ
www.cancer.org
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MICHIGAN Incidence
• NCI State Cancer Profiles (2005-
2009)
– 120 per 100,000 female
population/year
– 6,993 women / year
– ↓ 0.7%/year – not significant
http://statecancerprofiles.cancer.gov accessed February 23, 2013
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INCIDENCE
• Incidence drop in early
2000‟s felt to be related to
WHI Report and decreased
HRT use.
• Rate relatively steady for last
10 years.
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MORTALITY
• Estimated U.S. breast cancer
deaths in 2012 is 39,920
www.cancer.org
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SEER 2011
ACS 2012
-2.2% / year
1990-2008
-35%
Screening and
Treatment
USA Female Breast Cancer
Mortality Rate
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WHO IS AT RISK?
• 99 % of breast cancers develop in
women
– Median age 61 years
• 1 % in men
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Major Risk Factors for Breast Cancer
• Increasing age (age 25 = 1 in 19,608 vs. age 45 = 1 in 93)
• Family history (especially first degree relatives and premenopausal)
• Personal history
• Prior breast biopsy with atypia or LCIS
• Genetic mutations BRCA 1 and 2 (5-10% of all cases. )
• Thoracic Radiation Therapy (age < 30)
• Dense Breasts
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Other Risk Factors
• Early menarche (<12yo)
• Late menopause (> 52/55yo)
• Late age at first full term pregnancy (> 30yo)
• Nulliparity
• Post-menopausal obesity
• Hormone replacement therapy – Estrogen + Progesterone implicated in Women‟s Health
Initiative Study (2003)
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Mammography Screening
• Only modality with many years of
multiple large randomized clinical
trials demonstrating mortality
benefit.
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Mammography
• Diminished sensitivity in dense
breasts compare to fatty.
• Despite this it has been proven to
save lives
• **The breast density issue should
NOT discourage women from
getting mammograms**
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What is Breast density?
• Assessed on mammography
• Different X-ray absorption of fibrous
and glandular tissue vs fat.
• Density is the relative amount of
white (FG) vs black/gray (fat)
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How is breast density measured
and reported?
• Visual estimation of density
– Wolfe‟s Classification (1976)
• Hutzel Hospital, Detroit
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How is breast density measured
and reported?
• Wolfe’s Classification-Qualitative • N1-mostly fat
• P1- <¼ of breast is dense
• P2- >¼ of breast is dense
• DY- marked mammary dysplasia
– 37x Greater incidence of cancer in
DY vs N1 group
Wolfe JN Breast Patterns as a Index of risk for Developing Breast Cancer. AJR 1976:126:1130-1137
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How is breast density measured
and reported?
• Visual estimation of density
– Wolfe‟s Classification (1976)
– BI-RADS
• Computer Assisted
– MDEST (Mammographic Density
ESTimation)
– Cumulus®
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BI-RADS (Breast Imaging Reporting and Data System)
• Qualitative – 1- Almost entirely fat
– 2- Scattered fibroglandular densities
– 3- Heterogeneously dense
– 4- Extremely dense
American College of Radiology. Breast imaging Reporting and Data System (BI-RADS) 4th Ed. Reston, VA: American
College of Radiology: 2003
Ciatto et al The Breast vol 21, issue 4 August 2012, Pages 503–506
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Ciatto et al The Breast vol 21, issue 4 August 2012, Pages 503–506
BI-RADS
1 2 3 4
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BI-RADS
• Quantitative
– 1- Almost entirely fat <25% dense
– 2- Scattered fibroglandular densities 25-50%
– 3- Heterogeneously dense 50-75%
– 4- Extremely dense >75%
American College of Radiology. Breast imaging Reporting and Data System (BI-RADS) 4th Ed. Reston, VA: American College of Radiology: 2003
Ciatto et al The Breast vol 21, issue 4 August 2012, Pages 503–506
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How good are we at
estimating density? • 706 mammograms
• Assessed inter-observer agreement for
cancer detection and breast density using BI-
RADS
• Observed agreement-75%
• Agreement expected by chance-39%
• Κ=0.59 (0.55-0.62)
– Moderate agreement
Kerlikowske 1998 JNCI
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BI-RADS • Subjective
• Moderate reproducibility
• Qualitative > Quantitative
• More reliable in the lowest and
highest density. (Cat 1 and 4)
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Example of cranio-caudal image mammographic density readings in the 2-D
threshold percent density and the volumetric Standard Mammographic Form
methods.
Aitken Z et al. Screen Film Mammographic Density and Breast Cancer Risk:
A Comparison of the Volumetric Standard Mammographic Form and the
Interactive Threshold Measurement Methods Cancer Epidemiol Biomarkers
Prev 2010;19:418-428
2-D vs. 3-D
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Computerized methods
• Aitkin 2010
– 367 cancers/661 controls
– Compared % density 2D semi automated
system with 3D fully automated system
– % density 2D method better at predicting
risk of cancer.
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Density measurements
• No perfect measure yet
• BIRADS
– Current clinical standard
– Subjective
• Automated systems not ready for
the clinic
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BIRADS breast
density† # of women %
1 57,961 10
2 259,018 44
3 216,395 37
4 53,995 9
Adapted from Breast Cancer Risk by Breast Density, Menopause, and Postmenopausal Hormone
Therapy Use, Kerlikowske K. et al
J Clin Onc August 20, 2010 vol. 28 no. 24 3830-3837
587,369 women
>1 million mammo exams
Looking at 5 year breast cancer risk
Distribution of Breast Density
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Breast Density
Scattered
densities Heterogeneously
Dense
Predominantly
fatty
Extremely
Dense
# of
women
Breast Density
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Density and Breast Cancer Risk
• MASKING- Dense tissue hiding a
cancer on a mammogram
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Density and Breast Cancer Risk
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Density and Breast Cancer Risk
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Palpable left breast mass
36 years old
Heterogeneously dense
RT LT
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Density and Breast Cancer Risk
• Intrinsic increased risk of Cancer
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Density and Breast Cancer Risk
• Wolfe 1976 37x risk
• McCormack 2006 4-6x risk – Meta analysis
• 11 studies
• >14,000 cases
Wolfe, JN Risk for Breast Cancer Development Determined by Mammographic Parenchymal Pattern. Cancer
1976 May: 37(5) 2486-92
McCormack, VA et al, Breast Density and Parenchymal Patterns as Markers of Breast Cancer Risk. Cancer
Epidem Biomarkers Prev 2006; 15:1159-1169
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Association of Density classifications with breast cancer risk in general (incidence and prevalence)
McCormack V A , and dos Santos Silva I Cancer Epidemiol
Biomarkers Prev 2006;15:1159-1169
©2006 by American Association for Cancer Research
Relative risk
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Density and Breast Cancer Risk
• Wolfe 1976 37x risk
• McCormack 2006 4-6x risk
• Boyd 2007 4.7 odds ratio – Risk >75% dense vs < 10% dense
Boyd NF, Mammographic Density and the Risk and Detection of Breast Cancer N Engl J Med 356;3January 18,2007
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So far
• What is breast density
• How is it measured
• Importance in breast cancer risk
– Extremely dense breasts- highest risk
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What is being done with this
information?
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Breast Density
• Imaging
• Patient Counseling
• Patient demand
• Legislation
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Breast Imaging
• Digital Mammography
– X ray image converted into an
electronic signal > projected on
screen > manipulated
– 85% of units in USA are digital
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Breast Imaging
• Digital Mammography
– DMIST Trial- 2005
• ~43,000 women/33 centers/2 years
• Accuracy- Film Screen vs Digital
Pisano,ED et al, Diagnostic Performance of Digital vs Film Mammography for Breast Cancer Screening
N Engl J Med 2005; 353:1773-83
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Breast Imaging
• Digital Mammography
– DMIST Trial
• Accuracy higher for digital imaging
–Under age 50
–Dense breasts (>50% dense)
–Pre or peri-menopausal
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Film Screen Digital
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Supplemental Screening
• In addition to mammography!
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Breast Ultrasound
• Hand held US
– Inexpensive
– Available
– User dependent
– Time consuming
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Screening US
• Kolb 2002- 5,712 women/dense
breasts
– Screening Mammogram
– Screening hand held US
– PE
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Screening US
• Kolb: Cancers in dense breasts-
Sensitivity
– Mammo alone-64%
– US alone- 37%
– PE alone- 28%
– Mammo + US- 97.3%
– Mammo + PE- 74.7%
• P< .001
– False + approx 5%
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Screening US
• ACRIN 666
– Screening mammogram
– Screening US
– 2637 Women
• High risk AND >50% dense
• Based on personal hx, previous high risk
biopsy, Gail model
Berg WA, et al, Combined Screening With Ultrasound and Mammography vs
Mammography Alone in Women at Elevated Risk of Breast Cancer JAMA, 2008;
299, 2151-2163
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Screening US
• ACRIN 666
– 4.2 additional cancers/1000 women
supplemental yield by adding US
Berg WA, et al, Combined Screening With Ultrasound and Mammography vs
Mammography Alone in Women at Elevated Risk of Breast Cancer JAMA, 2008;
299, 2151-2163
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Screening US
False + PPV
Mammo alone 4.4 22.6 %
US alone 8.1 8.9 %
Mammo + US 10.4 11.2 %
ACRIN 666
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Connecticut Experience
• First Year after RU Dense Law
• 935 Women
• All risk levels
• Hand held whole breast
• 63 biopsies or aspirations
• 3/63 malignant – All <1cm
– All post menopausal
– 1 cancer per risk category
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Connecticut Experience
• Cancer detection rate: 3/1000
• PPV- 6.5% (low)
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Screening US • Benefits:
– Available
– Inexpensive
– No radiation
• Down sides:
– Time to perform study
• 19 minutes bilateral (ACRIN)
– Qualified physician/tech shortages
– False +
– Not standardized
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Automated US
• Speeds up exam
• Assisted robotic guidance of probe
over breast
U- Systems
SonixEmbrace
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Automated US
• Kelly et al, 2009
– 6,425 studies
– Increased cancer detection from 3.6
to 7.2/1000 compared to mammo
alone
– 7-8 minutes physician time
– PPV biopsy = 38.4%
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MRI
• Magnetic Resonance Imaging
• Increased availability in past 10 years
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MRI
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MRI
50 yo
Extensive non mass like
enhancement
DCIS
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CC MAG
MRI
62 yo Heterogeneously dense, 25% lifetime risk, screening
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MRI
MR Biopsy- High grade DCIS.
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MRI
• Benefits
– High sensitivity for cancer
– Not affected by density
– No Radiation
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MRI
• Down sides
– IV contrast required
– False +
– Claustrophobia
– Availability
– Cost
Berg WA Detection of Breast Cancer with Addition of annual Screening Ultrasound or a
Single Screening MRI to Mammography in Women with Elevated Breast Cancer Risk
JAMA 2012 ; 307:1394-1404
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MRI
– Berg 2012
– Expanded ACRIN trial: high risk AND
dense
– Added MRI screening after 3 rounds
of M/US
Berg WA Detection of Breast Cancer with Addition of annual Screening Ultrasound or a
Single Screening MRI to Mammography in Women with Elevated Breast Cancer Risk
JAMA 2012 ; 307:1394-1404
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MRI
• Results
– 612 women in MRI added group
– 16/612 had Cancer
– 9/16 (56%) seen only on MRI
• Median size 8mm
• All staged- node negative
– Supplemental cancer yield of MRI-
14.7/1000
Berg WA Detection of Breast Cancer with Addition of annual Screening Ultrasound or a
Single Screening MRI to Mammography in Women with Elevated Breast Cancer Risk
JAMA 2012 ; 307:1394-1404
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Berg 2012
Added MRI to ACRIN 666
Sensitivity Specificity PPV Recall
Rate
Mammo
alone
56% 89% 29% 11%
Mammo +
US
94% 74% 11% 16%
MRI 100% 70% 19% 31%
Berg WA Detection of Breast Cancer with Addition of annual Screening Ultrasound or a Single Screening MRI
to Mammography in Women with Elevated Breast Cancer Risk JAMA 2012 ; 307:1394-1404
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MRI
• Current recommendation for
screening MRI (NCCN)
– High risk women
– >20% lifetime risk of cancer
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Cost of supplemental studies
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Berg 2012
“Despite its higher sensitivity, the addition of
screening MRI rather than ultrasound to
mammography in broader populations of
women at intermediate risk with dense breasts
may not be appropriate, particularly when the
current high false positive rates, cost, and
reduced tolerability of MRI are considered.”
Berg WA Detection of Breast Cancer with Addition of annual Screening
Ultrasound or a Single Screening MRI to Mammography in Women
with Elevated Breast Cancer Risk JAMA 2012 ; 307:1394-1404
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Emerging Technologies
• Tomosynthesis
• Molecular Imaging
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Tomosynthesis
• Digital x-ray mammogram
• Multiple projections produced by x-
ray source that moves in an arc
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Basic technologic principles of breast tomosynthesis.
Park J M et al. Radiographics 2007;27:S231-S240
©2007 by Radiological Society of North America
Tomosynthesis
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Tomosynthesis
• Digital x-ray mammogram
• Multiple projections produced by x-
ray source that moves in an arc
• Interpretation of multiple slices thin
through breast like CT or MRI
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Tomosynthesis
*U. of Michigan Research
GE Prototype
U. Of M. Case 1
All tomo images courtesy of:
Marilyn A. Roubidoux, MD
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Tomosynthesis
*U. of Michigan Research
GE Prototype
DBT
U. Of M. Case 1
All tomo images courtesy of:
Marilyn A. Roubidoux, MD
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Case 1
Tomosynthesis DBT slices
Marilyn A. Roubidoux, MD
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Tomosynthesis DBT slice
U. Of M. Case 2
Marilyn A. Roubidoux, MD
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Screening digital
mammogram
CC MLO
Case 4
Tomosynthesis
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Case 4
CC MLO
DBT
Tomosynthesis
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MLO
Case 4
DBT slice
Tomosynthesis
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Case 5 Palpable lump
Tomosynthesis
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Tomosynthesis DBT DBT
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DBT slices
Tomosynthesis
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Tomosynthesis
• Benefits
– Decrease overlapping tissue
– Increased sensitivity
– Decrease size of cancer detected
– Decreased recall rate
– Uses mammographic technology
Helvie MA Digital Mammography Imaging: breast
Tomosynthesis and Advanced Imaging Radiol Clin N Amer
48(2010 917-929
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Tomosynthesis
• Benefits
– Decrease overlapping tissue
– Increased sensitivity
– Decrease size of cancer detected
– Decreased recall rate
– Uses mammographic technology
Helvie MA Digital Mammography Imaging: breast
Tomosynthesis and Advanced Imaging Radiol Clin N Amer
48(2010 917-929
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Tomosynthesis
• Skaane April 2013-
• 12,631 exams
• Digital Mammography and
Tomosynthesis
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Tomosynthesis
• Results
– 27% increase in cancer detection rate
when Tomo added (p= .001)
– 15% decrease in recall rates from
screening(p<.001)
– PPV of biopsy- same for M alone vs
M+Tomo
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Tomosynthesis
• Results
– Interpretation time doubled when
tomo added (45 vs 91 seconds
p<.001)
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Molecular Breast Imaging
• Positron Emission Mammography
(PEM)
– 18F-fluorodeoxyglucose
– High resolution PET scanner
• Breast Specific Gamma Imaging
(BSGI)
– Tc99m Sestamibi
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Molecular Breast Imaging
• Whole body exposure to ionizing
radiation
• Not indicated for annual use.
• Current trials underway to decrease
dose to allow for screening use.
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Are you DENSE?
© 2011 – 2013, Are You Dense Advocacy, Inc.. All rights reserved.
Site designed and hosted by WORX Branding & Advertising.. Email the webmaster.
Accessed 4-2-2013
Pink: Enacted law
Red: Endorsed Bill
Blue: Working on Bill
White: No Action
* : Insurance Coverage Bill
CT and IL mandate insurance coverage for
Screening US
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MICHIGAN Bill: patient notification
• "THE PHYSICIAN INTERPRETING YOUR MAMMOGRAPHY
EXAMINATION HAS DETERMINED THAT YOU HAVE DENSE
BREAST TISSUE. MAMMOGRAPHY HAS KNOWN LIMITATIONS
AND, IN A PATIENT WHO HAS DENSE BREAST TISSUE, SOME
ABNORMALITIES MAY NOT APPEAR. IF YOU WERE REFERRED
TO US BY A PHYSICIAN, A WRITTEN REPORT OF THE RESULTS
OF YOUR MAMMOGRAPHY EXAMINATION, INCLUDING
INFORMATION ABOUT YOUR BREAST DENSITY, HAS
BEEN SENT TO YOUR PHYSICIAN.
THIS NOTICE IS INTENDED TO RAISE YOUR AWARENESS AND
PROMOTE DISCUSSION BETWEEN YOU AND YOUR PHYSICIAN
REGARDING THE RESULTS OF YOUR MAMMOGRAPHY
EXAMINATION. DEPENDING UPON YOUR INDIVIDUAL RISK
FACTORS, YOUR PHYSICIAN MAY RECOMMEND ADDITIONAL
TESTS INCLUDING AN ULTRASOUND OR MAGNETIC RESONANCE
IMAGING. YOU SHOULD CONTACT YOUR PHYSICIAN IF YOU HAVE
ANY QUESTIONS OR CONCERNS REGARDING THE RESULTS OF
YOUR MAMMOGRAPHY EXAMINATION.".
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Are you Dense Legislation?
• The GOOD:
– Increased clinician and patient
awareness • Strengths and shortcomings of Mammography
• Risk factors
– Increase discussion with their
clinicians • Can address other risk factors
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Are you Dense Legislation?
• The Bad:
– Patient anxiety • Only 10% of screening population is extremely dense
– Significant risk seems to be directed at this group
• High false positives of supplemental studies
– Technology has not caught up- • Measuring breast density-limited
• Moderate reliability of description
• Computerized models very limited use now
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Are you Dense?
• The Ugly:
–Will this discourage women and
clinicians from routine
mammography?
–Who is going to pay for
supplemental studies?
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Recommendations
• Support education of public
– Data supports density as a risk factor
• Continue Annual Mammography
• Support Insurance coverage as a
necessary part of legislation to
ensure parity
• Consider limiting recommendation
to Extremely Dense breasts
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Thank you
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