sofia kitap renkli.indd

LITERATURES OF
WHOLE BREAST IMAGING
ULTRASOUND SYSTEMS
Table of Contents:
1. Amerika’da Meme Yoğunluğu Kanunu çıktı !
2. iVu Case Study
3. Breast density notification movement gains momentum
4. Dense breast masses 3 times more likely to be malignant
5. ACRIN 6666
Amerika’da Meme Yoğunluğu Kanunu çıktı !
Conneticut Eyaletinde yayınlanan Kanun (sSB 458 OLR) hastanın meme yoğunluk
statüsünün tarama raporunda yazılı olması zorunluluğunu açıkladı. Kanunda yoğun
meme dokusu olan hastaların Ultrason / Doppler veya özelliğine göre MRI
yaptırmasını Radyologun Mamografi raporunda önermesi de şart oldu. Conneticut
Kanunu bir meme taramasının tüm yazılı sonuçlarının hastaya verilmesini zorunlu
tutuyor. Buna the American College of Radiology’s Breast Imaging Reporting
and Data system (BI-RADS / Amerikan Meme Görüntüleme Raporlama ve Veri
Sistemi Fakültesi) baz alınarak hesaplanan meme yoğunluğu da dahildir. Hastalar
ayrıca eğer meme dokuları yoğunsa uyarılmalıdır.
Bu kanuna Conneticut’lu 2004 yılında ileri seviye meme kanseri teşhisi konulan 51
yaşındaki Dr. Nancy Cappello’nun tecrübesi neden oldu. Çünkü Cappello’da yoğun
meme dokusu vardı. O zamana kadar 10 kere düzenli olarak mamografi çektirmiş
olmasına rağmen kanseri yıllık mamografi tetkiklerinde fark edilmemişti. 3. derece
meme kanseri tedavisi gördükten sonra, Cappello “Are You Dense?” (Yoğun
musunuz?)’u kurdu. Bu kadınları yoğun meme dokusu konusunda bilgilenmeleri
ve meme kanserinin erken tanısı için ne kadar önemli olduğunu bilmeleri için
cesaretlendiren bir organizasyondur. “2004’te tedavim sırasında yoğun doku
konusunda bilgi bulabilmek için araştırma yaptım ve gördüm ki bu konuda 38.000
kadından fazlasının katıldığı 6 tane araştırma yapılmış. Sağlığım hakkında bilgi
benden saklanmıştı. Cerrahıma gidip neden kadınlara meme yoğunluğu hakkında
bilgi verilmediğini sorduğumda cevabı bunun standart protokol olmadığıydı ve ben ileri
seviyede kanserdim.” diyor.
Dünyaca ünlü Radyoloji haber ve makale sitesi Aunt Minnie’nin yazarlarından Kate
Madden Yee’ye göre; 2009’un Ekim ayında yürürlüğe giren Connecticut yasasını
yapanlar bunun genel nüfusu yoğun meme ve meme kanseri riski arasındaki bağlantı
ile ilgili toplumu eğitmek ve Ultrason gibi daha iyi sonuç veren tarama araçlarının
kullanımı için çok önemli bir adım olduğunu söylüyorlar.
Birçok klinik çalışma yoğun meme dokusu ve meme kanseri riski arasındaki bağlantıyı
göstermiştir. American Association for Cancer Research (AACR – Kanser
Araştırmaları için Amerikan Birliği) toplantısında sunumu yapılan bir araştırmaya göre
yoğun meme dokusuna sahip olan bayanların en azından %75’i az yoğun olan veya
hiç yoğun dokusu olmayan bayanlara göre 4 ve 5 kat daha fazla meme kanserine
yakalanma olasılığına sahipler.
Journal of the American Medical Association (Amerikan Medikal Birliği Bülteni)’de
2008 yılında yayınlanan ve American College of Radiology Imaging Network
(ACRIN – Amerikan Radyoloji Görüntüleme Fakültesi)’nden alınan veriye göre 6666
bayan üzerinde yapılan çalışma göstermiştir ki; 50 yaşından genç bayanların yarısının
yoğun meme dokusu var. Ayrıca 50 yaşın üstündeki bayanların %30’unda da yoğun
meme dokusu var. Yoğun meme dokusu olan bayanlarda mamografinin sağladığı
teşhis yapma imkanının yüksek kanser riski aralığında Klinik olarak teşhis edilmiş
kanserlerde en kötü prognoz ile %30 ve %48 kadar düşük olabiliyor. Araştırmanın
yazarı diyor ki aynı gruba Ultrason ile tarama yapıldığında duyarlılık %77.5’e kadar
artmaktadır. Bu nedenle erken tanı için Ultrason bütünleyici tarama aracı olarak
kullanılmalıdır.
Middletown’daki Middlesex Hastanesi radyoloji bölümünden Carol SchweitzerSchilling diyor ki; başta bu yeni yasa klinik pratiğini nasıl etkiler diye düşünmeye
başlamıştık ama sonra her şey yerli yerine oturdu. “ilk başta kanunun açık
gerekliliklerinin neler olduğu konusunda çok karmaşa vardı ama sonra Hasta
Raporlarımızı (tamamen kanuna göre) değiştirdik ve meme ultrasonu çektirmek
isteyen hasta sayısında önemli bir artış gördük, Ekim 2008 ile Mart 2009’u ve Ekim
2009 ile Mart 2010’u karşılaştırdığımızda ayda 150 kişi daha fazla çekim olduğunu
anladık. Bunun yanında geleneksel ultrason ile tarama yapmayı karmaşık yapan
konular vardır. Çift meme için ultrason taraması yapmak için gereken zaman
problemlidir. Prosedür uzundur her tarama için en azından 19 dakika gerekir. Bu
süreye önceki çalışmaların karşılaştırılması, hasta ile sonuçların tartışılması, veya
final raporunun hazırlanması bile dahil değildir.”
Erik Ridley’in Renkli Ultrason Doppler’in meme kanseri olan hastaların kanserden
kurtulma süreçlerindeki yararlarını anlattığı yazısında diyor ki; 50 hasta ile yapılan bir
araştırma göstermiştir ki kemoterapiden sonra Renkli Doppler taraması yapıldıysa
ve tümör içi kan akış hızının yükseldiğide görüldüyse bu demektir ki kanserin
tekerrür etme veya metastaz yapma ihtimali iki katına çıkmış oluyor. Bu veri tümör
içi kan akış hızının kemoterapiden sonra bu hız azalan hastalar ile karşılaştırılarak
sonuçlandırılmıştır (Ridley, 2010).
Dr. Gurpreet Singh ve araştırma ekibi (AIIMS) tarafından yazılan makale meme
kanseri hastalarına yapılacak olan tümör kan akış hızı ölçen Ultrason Doppler
taramasının hastalıktan tamamen kurtulmayı belirleyici bir yöntem olarak
kullanabileceğini ve eşsiz fonksiyonel bilgi sağlayacağını anlatıyor.
Ref.;
American Association for Cancer Research (2010, April 23). Mammographic density and risk of
breast cancer. ScienceDaily. Retrieved December 20, 2010
Yee, K.M. (2010). Conn. breast density law causes conundrum for mammo sites. AuntMinnie.com
Ridley, E.L. (2010). Color Doppler US predicts survival of breast cancer patients. AuntMinnie.com
CASE STUDY
Comparison of Radiological Findings for a High Risk Dense Breast Patient
(Mammography, Automated Whole Breast Ultrasound, and MRI)
Patient: The Patient is a 51 year old white female with a history of dense breast tissue
with fibrocystic features and large cysts requiring interventions in the past to alleviate
pain and motion related discomfort.
1. DIGITAL MAMMOGRAPHY
EXAM: MAMMO SCR BILAT DIGITAL W CAD
FINDINGS: “Routine digital mammograms were performed bilaterally and compared
to the prior study. The breast parenchyma is extremely dense which greatly lowers the
sensitivity of mammography. No suspicious calcifications are seen within either breast.
R2 CAD was utilized in the interpretation of this exam. Layering calcifications in the left
breast consistent with milk of calcium is noted. The breast tissue is not only incredibly
dense it is very nodular”.
IMPRESSION: “ 1. There is no mammographic evidence of malignancy in either breast.
2. Annual routine mammograms are recommended.
3. A negative mammogram report should not deter further clinical
evaluation if a dominant mass or a clinically suspicious area exists”.
2. AUTOMATED WHOLE BREAST ULTRASOUND (SOFIA™)
2D DICOM IMAGES
2D AXIAL IMAGES
3D MPR IMAGES (Whole Breast 3D, Axial, Coronal, Sagittal)
EXAM: AUTOMATED BILATERAL WHOLE BREAST ULTRASOUND (Sofia™ System1)
FINDINGS: Automated whole breast ultrasound exams were performed bilaterally. The
breast parenchyma is extremely dense which did not prevent the visualization of breast
tissue during the automated ultrasound procedure. Numerous cystic lesions and general
fibrocystic changes are observed bilaterally. A large 3cm fluid filled cyst is observed
in the left breast with regular margins and posterior enhancement. This cyst is palpable
on physical exam and is the cause of significant pain for the patient. Cystic lesions
bilaterally range in size from .25 cm to 3cm. Milk ducts are observed superficially. The
breast tissue exhibits considerable density and nodularity bilaterally.
IMPRESSION: 1. Intervention to remove fluid from the large 3cm cyst in the right
breast should be considered to alleviate pain and discomfort.
2. Repeat automated whole breast ultrasound within six months for
temporal comparison of areas of interest.
3. There is no ultrasound evidence of malignancy in either breast.
3. MRI
EXAM: BREAST MRI
FINDINGS:
Right Breast: There is extremely dense breast parenchyma with moderate background
enhancement on the right. Numerous cysts are scattered throughout the breasts. I see no
evidence of speculated or linear beaded enhancement to suggest malignancy. The nipple
areolar complex is unremarkable. A lump marker is placed over an area of palpable
concern at about 8 o’clock, but this is over dense but benign-appearing parenchyma with
no associated enhancement. No speculated or linear beaded enhancement is present to
suggest malignancy. A few scattered enhancing foci are demonstrated. The visualized
lymph nodes are architecturally preserved.
Left Breast: There is extremely dense breast parenchyma on the left with mild
background enhancement. A large, dominant cyst is present at about 3 o’clock on the
left in the location of the patient’s palpable concern. Numerous additional cysts are
identified. Some scattered enhancing foci are also noted on the left similar to the opposite
side. No speculated or linear beaded enhancement is present to suggest malignancy. The
nipple areolar complex is unremarkable. The visualized lymph nodes are architecturally
preserved.
IMPRESSION: 1. Bilateral fibrocystic change.
2. There is no definite MRI evidence to suggest malignancy on the
right or the left.
1.The Sofia™ Automated Whole Breast Ultrasound System from iVu Imaging Corporation was used to
acquire the ultrasound images in this study. The Sofia™ system acquires 120 images per breast during an
automated scan of 360°. The scan time per breast is approximately Three (3) minutes.
Breast density notification movement gains momentum
By Kate Madden Yee, AuntMinnie.com staff writer
April 14, 2011 -- In the 18 months since Connecticut passed a law mandating that women undergoing
mammography be informed of their breast tissue density rating, more states have begun considering
similar legislation.
In addition to requiring that women be educated about their breast tissue density, many of the bills
state that health insurers must pay for additional screening if a mammogram shows dense tissue. And
density awareness advocates hope radiologists can help their cause by telling referring physicians about
the importance of breast density in assessing a woman’s risk of breast cancer.
In October 2009, Connecticut passed a law requiring that written mammography results given to
patients include information about breast density based on the American College of Radiology’s (ACR)
BI-RADS lexicon. In that same year, the state of Illinois passed Public Act 95-1045, declaring that if
a routine mammogram reveals dense breast tissue, payors must cover a comprehensive ultrasound
screening of an entire breast or breasts, when determined to be medically necessary by a physician.
The Connecticut bill was prompted in part by the experience of Nancy Cappello, PhD, a Connecticut
woman who received a diagnosis of advanced-stage breast cancer in 2004, at age 51. Because Cappello
had dense breast tissue, her cancer was not discovered by annual mammograms, even though she had
already received more than 10. To address the issue of breast density, Cappello founded Are You Dense,
an organization that urges women to be informed about dense breast tissue and how it affects early
detection of breast cancer.
Out of Are You Dense has come the Density Education National Survivors’ Effort (DENSE), a grassroots
organization that supports further breast density notification legislation, Cappello told AuntMinnie.com.
“I started getting emails on my website from women with similar stories, who were diagnosed with
cancer at a later stage than necessary and never knew anything about breast density,” she said. “DENSE
came out of those contacts.”
The density bandwagon
Many more states are now drafting or presenting similar legislation. In January, Texas state Sen.
Rodney Ellis (D-Houston) introduced SB 1381, and state Rep. Ana Hernandez (D-Houston) is sponsoring
corresponding bill HB 834. In February, California state Sen. Joe Simitian (D-Palo Alto) introduced bill SB
173, which calls for healthcare service plan contracts and health insurance policies to include additional
benefits for comprehensive ultrasound screening under certain circumstances. It would also require
women receiving treatment under those coverage provisions to be informed of their breast density.
And in New York, state Sen. John Flanagan (D-2nd District) introduced bill S1883A, which calls for health
insurance policies to provide additional coverage for supplementary screening tests if a mammogram
shows dense breast tissue.
Other efforts include the following:
•Florida state Rep. Elaine Schwartz (D-Hollywood) is sponsoring HB 25, while state Sen. Jeremy Ring
(D-Margate) is sponsoring SB 96; both seek to attach breast density advisories to mammogram results.
•Massachusetts state Rep. Kathi-Anne Reinstein (D-Revere) plans to introduce a breast density bill this
year.
•States such as Kansas, Missouri, New Hampshire, and Ohio are actively seeking sponsors for similar
legislative action.
On the national level, Rep. Steve Israel (D-NY) and Rep. Rosa DeLauro (D-CT) are working on a federal bill
that would ensure that women receive information on breast density in their mammography reports.
Even breast cancer research giant Susan G. Komen for the Cure has come out in support of women
being informed of their breast density, Cappello said.
“The movement is spreading,” she said. “We’re organized, and we’re being strategic in how we’re
working with radiologists and legislators.”
What can radiologists do to spread the word to patients about breast density? Buddy up with referring
physicians, according to Cappello.
“Radiologists need to work with referring physicians,” she said. “Many referring physicians don’t
understand the issue of breast density. They look at the BI-RADS rating, and if the woman’s OK, they’re
done. But she may not be OK.”
Copyright © 2011 AuntMinnie.com
Last Updated np 4/14/2011 11:25:37 AM
Dense breast masses 3 times more likely to be malignant
By Kate Madden Yee, AuntMinnie.com staff writer
January 6, 2011 -- High-density breast masses are three times more likely to be malignant than their low-density
counterparts, according to new research published online in Radiology. And adding mass density to already
established predictors such as a lesion’s margin and shape could help reduce unnecessary biopsies.
That’s according to a University of Wisconsin, Madison, research team led by Ryan Woods, MD. The group examined
348 consecutive breast masses in 328 women who had image-guided or surgical biopsy between October 2005 and
December 2007 (Radiology, December 21, 2010).
“There are several things mammographers use to determine whether a mass is malignant and therefore should be
biopsied,” Woods told AuntMinnie.com. “We primarily use margin and shape of mass. But density can also be a
factor.”
Analog mammography exams were performed with Senographe DMR (GE Healthcare, Chalfont St. Giles, U.K.)
or M-IV (Hologic, Bedford, MA) units; digital mammography exams were taken with Senographe 2000D (also GE
Healthcare). Women received analog or digital exams depending on availability.
Three radiologists retrospectively assessed mass density of the 348 lesions. Of the 348, 180 (51.7%) had been
prospectively assessed for mass density at the time of initial interpretation, the authors wrote; one radiologist
assessed these 180 lesions for density.
Of the 348 lesions retrospectively assessed, 70.2% of high-density masses were malignant, while 22.3% of lowdensity masses were malignant. In the prospective assessment, high density, irregular shape, spiculated margins,
and patient age were associated with breast lesion malignancy, according to the authors.
Mammographic image of a low-density mass (arrow). All images courtesy of the Radiological
Society of North America.
Mammographic image of an isodense mass (arrow).
Mammographic image of a high-density mass (arrow).
Other studies have tried to determine whether mass density is useful for evaluating breast lesion malignancy, but
they have run into the challenge of how to compare lesions to an equal volume of healthy breast tissue. This study
differed from these others in its retrospective and prospective analysis, and the use of a logistic regression model to
analyze results, according to Woods and colleagues.
Adding the factor of a breast lesion’s density to clinical assessment could help stratify the risk of malignancy, and help
radiologists improve the positive predictive value (PPV) of biopsy, the authors wrote. The study found that the PPV
of high mass density was slightly greater than 70% -- which doesn’t suggest that mass density is sufficient in itself to
obviate the need for biopsy. But it could be used with the additional factors of mass margin and shape.
Previous research has found that overall breast density -- as opposed to the density of a particular mass -- can be
a predictor of a women’s cancer risk. But the current study actually found that women with lower breast density had
greater likelihood of having malignant lesions than women with high-density breast tissue. Woods’ team attributed this
finding to the fact that the women in the cohort with malignancies were older and had lower-density breast tissue.
The study shows that breast mass density is a significant predictor of malignancy, even after controlling for other
variables, according to the authors. Radiologists should consider the density of a mass as they try to stratify a
woman’s cancer risk.
“If this kind of research helps women make better decisions about biopsy, that’s great,” Woods said. “That’s our goal- to be able to tell a patient that she can safely forego a needle biopsy.”
By Kate Madden Yee
AuntMinnie.com staff writer
January 6, 2011