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SCREENING BREAST ULTRASOUND
(US)
STAMATIA DESTOUNIS MD, FACR
ELIZABETH WENDE BREAST CARE, LLC.
CLINICAL PROFESSOR UNIVERSITY OF ROCHESTER
DISCLOSURE OF
COMMERCIAL INTEREST
Neither I nor my immediate
family members have a
financial relationship with a
commercial organization that
may have a direct or indirect
interest in the content
66 y/o presents for screening mammography
BI-RADS density: d
Screening US performed due to dense tissue
US guided biopsy: Invasive Ductal Carcinoma
BREAST DENSITY INFORM LAW
Mammography reports must include information about
breast density based on the four BI-RADS® density
categories: a, b, c, d
Mammography report states: the state law requirement
for reporting breast density, what was reported to the
patient and that the patient may be contacting their
physicians to discuss breast cancer risk and other useful
screening tests
Patient breast density notification report is generated in
lay terms informing the woman of her breast density
BREAST DENSITY LEGISLATION
Women with dense tissue have a 3 to 5 times greater risk of
developing breast cancer
31%-43% of the general screening population have
heterogeneously dense or extremely dense breasts
US is likely the most promising adjunct screening modality due
to its low costs and availability
US detected cancers are often node negative leading to
earlier treatment for lower-stage invasive cancers ultimately leading to improved patient survival
Lee, CI, et al. Breast Density Legislation and Opportunities for Patient-
centered Outcomes Research. Radiology 2012. 264(3). 632-636
State Law Requiring
Communication of Breast Density
Pink: Enacted Law
Red: Introduced Bill
Blue: Working on Bill
White: No Action
Black Star: Insurance
Coverage Law
http://areyoudenseadvocacy.org/dense/ accessed 2.26.16
SCREENING US STUDIES
AFTER MANDATES
Studies showing encouraging results with adjunct
screening ultrasound
► Parris et al. Parris T, et al. The Breast Journal 2013
► Hooley et al. Radiology 2012
► Weigert, J et al. The Breast Journal 2012
► Weigert J, Steenbergen S. The Breast Journal 2015
PARRIS ET AL.
Pre Law 10/08-9/091319 screened with US
20 biopsies
All benign
Post Law 10/09-09/105519 screened with US
181 Invasive procedures
11 cyst aspirations
170 US guided biopsy
10 malignant lesions
160 benign lesions
Parris T, et al. Real World Performance of Screening Breast Ultrasound Following Enactment of Connecticut Bill 458. The Breast Journal 2013; 19 (1): 64-70
Retrospective evaluation of the benefits of screening breast US in women
with dense breast tissue following enactment of Connecticut Bill 458
A formal screening US program as an adjunct to mammography in
women with dense breasts increased the cancer detection rate
PARRIS ET AL.
Real world performance following enactment of Connecticut Bill
10 malignant lesions
Cancer detection rate- 0.18%
Biopsy rate- 3.3%
Positive predictive value- 5.5%
Tumor size on ultrasound ranged from 4 to 15 mm
Parris T, et al. Real World Performance of Screening Breast Ultrasound Following
Enactment of Connecticut Bill 458. The Breast Journal 2013; 19 (1): 64-70
HOOLEY ET AL.
935 women
614 (65.7%) were at low risk
149 (15.9%) were at intermediate risk
87 (9.3%) were at high risk
63 biopsies and aspirations
3 malignant
All were: smaller than 1 cm; found in postmenopausal
patients; solid masses
1 cancer was found in each risk group
Overall cancer detection rate was 3.2 cancers per 1000
women screened
Hooley et al. Screening US in Patients with Mammographically Dense Breasts:
Initial Experience with Connecticut Public Act 09-41. Radiology 2012; 265: 59-69
Connecticut Public Act 09-41: First year experience
of the Screening US in patients with dense breasts
WEIGERT ET AL.
The Connecticut Experiment
72,030 screening mammograms and 8,647 screening
ultrasounds
429 had a biopsy recommendation
418 biopsies
28 cancers
Screening ultrasound had an additional yield of 3.25 per 1,000
cancers in women with dense breasts and normal mammograms and no additional risk factors
Weigert, J et al. The Connecticut Experiment: The Role of Ultrasound in the
Screening of Women With Dense Breasts. The Breast Journal 2012; 18 (6): 517–522
WEIGERT: 2nd YEAR
57417 screening mammograms
10,282 dense breast US examinations
39 cancer/high risk lesions
When eliminating the high risk lesions
2.3 cancers per 1,000
Study showed an improved specificity and
sensitivity between the 1st and 2nd year
suggesting a learning curve that may continue
to improve results
Weigert J, Steenbergen S. The Connecticut Experiments Second Year: Ultrasound in the Screening of Women with Dense Breasts. The Breast Journal Vol. 21 Number 2, 2015 pp 175-180
SCREENING US
Automated Breast US (AB US):
► Improved consistency and exam reproducibility
► Studies can be reviewed at a later time
► Entire dataset acquired at imaging can be viewed
► Time intensive reading due to large dataset
► Can lesions be missed due to large dataset?
Hand Held US (HH US):
► User dependent
► Time intensive
► Lack of qualified individuals: radiologist, sonographer
AB US
Systematically scans the breast capturing
up to 350-600 ultrasound images
Images can be manipulated to produce
a 3D reconstruction of the breast
Allows for visualization of the entire breast
Reproducible
AB US STUDY: RADIOLOGY
2015
Brem et al. assessed improvement in breast
cancer detection with 3D AB US
SomoInsight prospective study conducted
between 2009 and 2011 enrolled 15,318
women with dense breast tissue with
screening mammography and AB US
112 cancers
82 with screening mammography
An additional 30 with AB US
Brem R, Tabar L, Duffy SW, et al. Assessing Improvement in Detection of Breast cancer with Three-dimensional Automated Breast US in women With Dense Breast Tissue: The SomoInsight Study Radiology Vol 274: Number 3 March 2015 663-673
AB US STUDY: CLINICAL
IMAGING 2013 Giuliano and Giuliano reported on ABUS examinations
performed on asymptomatic women with breast density of 50% or greater
Control group: 4076 asymptomatic women with breast density of 50% or greater having FFDM only
19 cancers
Cancer detection rate: 4.6 per 1,000
Test group: 3,418 asymptomatic women with breast density of 50% or greater had FFDM followed by ABUS (FFDM alone results were not used as control to avoid bias)
42 cancers
Cancer detection rate: 12.3 per 1,000
Giuliano V, Giuliano C. Improved breast cancer detection in asymptomatic women using 3D-automated breast ultrasound in mammographically dense breasts. Clinical Imaging 37 (2013) 480-486
AB US
FDA approval for use in combination with
mammography for screening in asymptomatic
women with dense breast tissue
► Large field of view transducer
► 3D workstation enables image interpretation
17cm
15.4cm
4cm
Courtesy of GE
GE
Lateral
MedialAP
IMAGE ACQUISITION
Courtesy of GE
ACQUISITION/
INTERPRETATION
Acquire images
► Automated image acquisition
► 15cm field-of-view transducer
► Image acquisition time: 45 seconds per view
► Average study is 3 views per breast
► Total exam time ~ 15 minutes once fully trained
Interpret images
► Review 3D image sets on workstation
► Read entire case in ~3 to 5 minutes once fully
trained
Cluster of CystsCourtesy of GE
Multiple FibroadenomasCourtesy of GE
Extremely Dense Tissue – Normal StudyCourtesy of GE
Biopsy-proven Invasive Ductal CarcinomaCourtesy of GE
iVu SOFIA
Automated Breast Tomography
Whole Breast Automated
Image Acquisition
2D, 3D, MPR Visualization and
Analysis
3D Volume
Utilizes already existing US
unit/probes
52 second imaging time per
breast
Courtesy of Hitachi-Aloka
Courtesy of Hitachi-Aloka
Review time: 1 minute per breast
Courtesy of Siemens
SIEMENS ABVS
Courtesy of Siemens
Duct
Courtesy of Siemens
Hypoechoic finding
SONOCINE
Automated whole breast US
(AWBUS)
Accessory to your existing US
system, not a replacement
Uses your transducer(s)
Courtesy of SonoCine
HANDHELD ULTRASOUND
User dependent
High image quality
Understand the technical aspects of the equipment
Patient positioning
Transducer selection
Image resolution
Focal zone
Depth
Gain
Spatial compound imaging
Harmonics
Color Doppler and power Doppler
Real time imaging
Sung JS. High Quality Breast Ultrasonography. Radiol Clin N Am. 52 (2014) 519-526
COMMENTARY IN
RADIOLOGY
Drs. Berg and Mendelson reviewed the current status
on technologist performed HH screening US
Normal screening examination
A minimum of one image of each quadrant and
one behind the nipple should be obtained
Berg WA, Mendelson EB. Technologist-performed Handheld Screening Breast US Imaging: How Is It Performed and What Are the Outcomes to Date? Radiology: Volume 272: Number 1 July 2014
2015 CPT CODES
Code 76641
Represents a complete unilateral US examination
of the breast
All four quadrants
Retroareolar region
Axilla, if performed
* When performing a bilateral screening US, one would
need to bill twice and accordingly per insurance
carrier specifications
Current Procedural Terminology 2015: Professional Edition
HANDHELD ULTRASOUND
Our experience with Hand-held screening US
Physicians: 7
Sonographers: 3 full time
Increased staff to accommodate the rise in screening
US examinations post mandate
PRIOR TO THE 2013
MANDATE (NY STATE)
Breast tissue assessment by physician
76,628 screening mammograms
Dense tissue – 7%
Heterogeneously dense tissue – 45%
Scattered tissue – 46%
Fatty replaced tissue – 2%
Estimated that ~50% of our patients would receive the
notification that their breast density was either
heterogeneously dense or extremely dense
AFTER THE 2013 MANDATE
(NY STATE)
Automated tissue assessment (Volpara)
Total of 72,882 screening mammograms
Dense tissue – 8,090 (11%)
Heterogeneously dense tissue – 25,546 (35%)
Scattered tissue – 31,061 (43%)
Fatty replaced tissue – 8,185 (11%)
46% (33,636) received notification that their breast
density was either heterogeneously dense or
extremely dense
SCREENING US EXPERIENCE
102,841 screening mammograms between 1/1/2013 and 5/31/14
971 HH screening US exams in 935 patients performed due to the designation of dense breast tissue
619 (66%) patients with heterogeneously dense tissue
316 (34%) patients with extremely dense tissue
25 (2.6%) procedures were performed
22 benign findings
1 atypical finding
2 malignant findings
HH screening US performed in women with dense breast tissue can aid in the detection of otherwise mammographically occult cancer, with an overall PPV of 8%
Destounis et al. Initial Experience with New York State Breast Density Inform Law at a Community-Based Breast Center. J Ultrasound Med 2015; 34:993-1000
Screening US To Date
January 1, 2013 through December 31, 2015
5,692 HH screening US examinations performed due to the designation of heterogeneously dense or extremely dense breast tissue
68% (n=3872) heterogeneously dense
32% (n=1820) extremely dense
88 (1.5%) procedures were performed
79 needle core biopsies and 9 fine needle aspiration biopsies
Resulting in 71 benign findings, 3 atypical findings and 14 malignant findings
In our experience, HH screening US performed in women with dense breast tissue can aid in the detection of otherwise mammographically occult cancer at a rate of 2.5 per 1,000
DENSITY DISTRIBUTION
0
5
10
15
20
25
30
35
40
45
50
Dense Het Dense Scattered Fatty
Density Percentage
2012 (76,628) 2013 (72,882) 2014 (72896) 2015 (70784)
CASE
50 y/o presents for screening mammography and
screening US due to heterogeneously dense breast tissue
Family history of 2 grandmothers with breast cancer
Right breast prior benign biopsy
US guided biopsy: Invasive Ductal Carcinoma
Case
52 y/o presents for screening US after
Heterogeneously dense breast tissue was identified at screening mammography
Bilateral saline implants
Family history of breast cancer: aunt-age 78
Scattered simple cysts are identified
Irregular hypoechoic nodule
Core biopsy=IDC, Nuclear Grade 1
OSB=IDC, DCIS, Grade 1, node negative
Case
55 y/o presents for screening US after
Heterogeneously dense breast tissue was identified at screening mammography
History of left breast benign core biopsies
Normal screening ultrasound examination
CASE
52 y/o presents for screening
mammography and screening US
Prior left lumpectomy and radiation for
DCIS in 2007
US guided core biopsy: IDC
SUMMARY
Screening US resulted in 88 procedures
14 cancers
Screening US identifies cancers that would go
otherwise undetected at a rate of 2.5 per 1,000