8
ORIGINAL ARTICLE Real-time tissue elastography combined with BIRADS-US classification system for improving breast lesion evaluation Fatma Zeinhom Moukhtar a , Amal Amin Abu ElMaati b, * a Department of Radio Diagnosis, Cairo University, Egypt b Department of Radio Diagnosis, Ain Shams University, Egypt Received 6 May 2014; accepted 14 May 2014 Available online 14 June 2014 KEYWORDS B-mode ultrasound; Real-time tissue elastography; BIRADS-US; TES Abstract Purpose: The purpose of this study was to establish the correlation of prospectively interpreted ultrasound elastography (USE) results with American College of Radiology Breast Imaging Reporting and Data System (BIRADS) assessment and pathologic diagnoses of sono- graphically visible breast masses and to determine whether USE can improve distinction of benign and malignant lesions. Patients and methods: Between April 2012 and January 2014, sonoelastography of focal breast lesions was carried out in 410 patients with subsequent histological confirmation. We present data focusing on the sensitivity (SE), specificity (SP) and the positive (PPV) and negative predictive value (NPV) of sonoelastography. In addition we performed an analysis of the diagnostic performance, expressed by the pretest and posttest probability of disease (POD), in BI-RADS-US 3 or 4 lesions as these categories can imply both malignant and benign lesions and a more precise prediction would be a preferable aim. Results: Sonoelastography demonstrated an improved SP (89.5%) and an excellent PPV (86.8%) compared to B-mode ultrasound (76.1% and 77.2%). Especially in dense breasts ACR III–IV, the SP was even higher (92.8%). In BI-RADS-US 3 lesions, a suspicious elastogram significantly mod- ified the POD from 8.3% to a posttest POD of 45.5%. In BI-RADS-US 4 lesions, we found a pre- test POD of 56.6%. The posttest POD changed significantly to 24.2% with a normal elastogram * Corresponding author. Tel.: +20 1223558198; fax: +20 222687239. E-mail addresses: [email protected], [email protected] (A.A.A. ElMaati). Peer review under responsibility of Egyptian Society of Radiology and Nuclear Medicine. The Egyptian Journal of Radiology and Nuclear Medicine (2014) 45, 1021–1028 Egyptian Society of Radiology and Nuclear Medicine The Egyptian Journal of Radiology and Nuclear Medicine www.elsevier.com/locate/ejrnm www.sciencedirect.com 0378-603X Ó 2014 Production and hosting by Elsevier B.V. on behalf of Egyptian Society of Radiology and Nuclear Medicine. http://dx.doi.org/10.1016/j.ejrnm.2014.05.007 Open access under CC BY-NC-ND license.

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Page 1: Real-time tissue elastography combined with BIRADS-US ... · lesions, improving specificity, particularly for BIRADS 3 and BIRADS 4 lesions. 2014 Production and hosting by Elsevier

The Egyptian Journal of Radiology and Nuclear Medicine (2014) 45, 1021–1028

Egyptian Society of Radiology and Nuclear Medicine

The Egyptian Journal of Radiology andNuclearMedicine

www.elsevier.com/locate/ejrnmwww.sciencedirect.com

ORIGINAL ARTICLE

Real-time tissue elastography combined

with BIRADS-US classification system

for improving breast lesion evaluation

* Corresponding author. Tel.: +20 1223558198; fax: +20 222687239.E-mail addresses: [email protected], [email protected]

(A.A.A. ElMaati).

Peer review under responsibility of Egyptian Society of Radiology and

Nuclear Medicine.

0378-603X � 2014 Production and hosting by Elsevier B.V. on behalf of Egyptian Society of Radiology and Nuclear Medicine.

http://dx.doi.org/10.1016/j.ejrnm.2014.05.007Open access under CC BY-NC-ND license.

Fatma Zeinhom Moukhtara, Amal Amin Abu ElMaati

b,*

a Department of Radio Diagnosis, Cairo University, Egyptb Department of Radio Diagnosis, Ain Shams University, Egypt

Received 6 May 2014; accepted 14 May 2014

Available online 14 June 2014

KEYWORDS

B-mode ultrasound;

Real-time tissue

elastography;

BIRADS-US;

TES

Abstract Purpose: The purpose of this study was to establish the correlation of prospectively

interpreted ultrasound elastography (USE) results with American College of Radiology Breast

Imaging Reporting and Data System (BIRADS) assessment and pathologic diagnoses of sono-

graphically visible breast masses and to determine whether USE can improve distinction of benign

and malignant lesions.

Patients and methods: Between April 2012 and January 2014, sonoelastography of focal breast

lesions was carried out in 410 patients with subsequent histological confirmation. We present data

focusing on the sensitivity (SE), specificity (SP) and the positive (PPV) and negative predictive value

(NPV) of sonoelastography. In addition we performed an analysis of the diagnostic performance,

expressed by the pretest and posttest probability of disease (POD), in BI-RADS-US 3 or 4 lesions

as these categories can imply both malignant and benign lesions and a more precise prediction

would be a preferable aim.

Results: Sonoelastography demonstrated an improved SP (89.5%) and an excellent PPV (86.8%)

compared to B-mode ultrasound (76.1% and 77.2%). Especially in dense breasts ACR III–IV, the

SP was even higher (92.8%). In BI-RADS-US 3 lesions, a suspicious elastogram significantly mod-

ified the POD from 8.3% to a posttest POD of 45.5%. In BI-RADS-US 4 lesions, we found a pre-

test POD of 56.6%. The posttest POD changed significantly to 24.2% with a normal elastogram

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1022 F.Z. Moukhtar, A.A.A. ElMaati

and to 81.5% with a suspicious elastogram.

Conclusions: Real-time tissue elastography may provide additional characterization of breast

lesions, improving specificity, particularly for BIRADS 3 and BIRADS 4 lesions.

� 2014 Production and hosting by Elsevier B.V. on behalf of Egyptian Society of Radiology and Nuclear

Medicine. Open access under CC BY-NC-ND license.

1. Introduction

Breast ultrasound elastography (USE) is a new technique ofultrasonic imaging that has shown effectiveness for detectionof malignancy within breast lesions. USE provides informationabout the mechanical properties of tissue such as elasticity and

strain and maps it into color images (1–4). Elasticity is the ten-dency of a tissue to resume the original size and shape; whilestrain is the level of change in size or shape in response to

external compression (stress) (4). Each pixel of the image isassigned one of 256 specific colors and demonstrates the mag-nitude of tissue strain depending on physiological and patho-

logical changes in breast structure (3,5). Harder tissues suchas malignancy may result in decreased strain and are shownin blue, while softer tissues will reflect increased strain andare shown in red (3). Normal breast tissue which reflects aver-

age strain is shown in green (3). The color image is superim-posed on B-mode ultrasound (US) image for a betterrecognition of the relationship between the strain distribution

and the anatomical borders of the lesion (3,4,6). This informa-tion is further interpreted by evaluating the color pattern in ahypoechoic lesion (e.g., within lesion borders on US image),

and in the surrounding breast tissue (3). A 1–5 scale elasticityscore (ES) is assigned to each image based on its overall pat-tern, with the harder tissues (e.g. breast cancer) showing higher

elasticity scores (3). Although characterization of solid breastmasses by sonography has improved greatly since the early1990s, specificity remains low, and to date a large number ofbreast biopsies result in benign diagnoses. Therefore, any addi-

tional sonographic information to improve lesion characteriza-tion would help increase specificity. Recently published studieshave reported promising results using elasticity imaging, either

in comparison with B-mode sonography or in conjunction withthe B-mode findings (7–9).

A significant number of false positive and false-negative

findings still occur (10). The consequence of a false-positiveresult in diagnostic imaging is the performance of an unneces-sary biopsy. A false-negative result has an even more serious

implication as the diagnosis of malignancy is delayed, with apotentially worse clinical outcome for the patient. In orderto prevent excessive biopsies on the one hand and, in particu-lar, to guarantee the highest level of patient safety on the other

hand, diagnostic methods should be continuously refined.Today, ultrasound (US) plays a decisive role in the diagnos-

tic pathways, with high sensitivity and specificity (11). Despite

technical advances, the most important step in bringing breastUS to its current position was the introduction of the stan-dardized BI-RADS-US-classification system by the American

College of Radiology (ACR) (12).The ACR BI-RADS-US lexicon provides various catego-

ries with predefined terminology to describe the dominant fea-tures of breast lesions accurately. According to the ACR, each

lesion should be assigned a BI-RADS-US category rangingfrom BI-RADS-US 0 to BI-RADS-US 6 at the end of the diag-

nostic procedure (12). The distinct BI-RADS-US classificationalso implies what further clinical action should be taken: BI-RADS-US 4 lesions are possibly malignant and BI-RADS-

US 5 lesions are probably malignant. Therefore, the appropri-ate consequence is a biopsy, usually under US guidance.Malignancy practically never occurs in BI-RADS-US 2

lesions, which are defined as benign findings. To our under-standing, the group of BI-RADS-US 3 lesions remains a crit-ical category. These findings are probably benign and short-term follow-ups are recommended. Nevertheless, malignancy

is eventually diagnosed in about 3% of these lesions, resultingin a delayed diagnosis of cancer in a considerable number ofpatients (13). Therefore, a suitable predictor for malignancy

in BI-RADS -US 3 lesions would be beneficial and of clinicalrelevance. Nowadays, newly developed US technologies mayallow a better differentiation of benign and malignant masses

(14).The goal of our study was to determine the usefulness of

USE in the evaluation of solid masses or indeterminate breastlesions in a clinical setting with pathology as the reference

standard. Specifically, our aim was to establish the correlationof prospectively interpreted USE results with American Col-lege of Radiology Breast Imaging Reporting and Data System

(BIRADS) assessment and pathologic diagnoses of sonograph-ically visible breast masses and to determine whether USE canimprove distinction of benign and malignant lesions, thereby

increasing specificity and positive predictive value.The aim of our study is to focus on the application of USE

for further characterization of lesions that are initially catego-

rized as BI-RADS-US 3 or 4 as these categories can imply bothmalignant and benign lesions and a more precise prediction ofa lesion’s malignancy status in these categories would bevaluable.

2. Patients and methods

2.1. Patients

We performed 410 ultrasound examinations at a private center

between April 2012 and January 2014. The patients werereferred to the center due to specific diagnostic queries suchas palpable breast lesions, pain, suspicious mammograms,

breast cancer follow-up or intensified screening in high-riskpopulations. Patients, who presented a lesion in B-mode ultra-sound that required the taking of a histological specimen, were

considered to be suitable for the study, and additional elasto-graphic examination was carried out. Finally the patients werescheduled to undergo ultrasound-guided core needle biopsy ofthe breast lesion. The age of the patients ranged from 18 to

72 years (mean, 42.6 years).

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Real-time tissue elastography for breast lesion evaluation 1023

2.2. Ultrasound examinations and biopsy procedures

Ultrasound and elastography images were obtained by using a6–14 MHz linear array transducer (Toshiba Aplio XG ultra-sound machine). Real-time whole breast ultrasound examina-

tion was performed by an experienced radiologist (with10 years of experience in breast imaging).

After the whole breast ultrasound examination, ultrasoundand elastography were performed sequentially only at the

lesion subjected to biopsy. In order to make the images compa-rable to each other and to perform the analysis, each elasto-gram had to include a complete sectional plane of the tumor

as well as an adequate (more than approximately 50% of thearea) amount of surrounding normal breast tissue.

Biopsy was performed by the same radiologist who per-

formed the whole breast ultrasound examination. Local anes-thesia (1% lidocaine) was routinely applied, and an automatedgun (Pro-Mag 2.2, Manan Medical Products) and a 14-gauge

True Cut needle with a 22-mm throw (SACN Biopsy Needle,Medical Device Technologies) were used. Informed patientconsent was obtained for all biopsy procedures.

2.3. Real-time ultrasound elastography

Ultrasound elastography was performed using a freehandtechnique at the same time as ultrasound. Images were

obtained by applying repetitive light compression at the skinabove the targeted breast lesion. The probe was positionedperpendicular to the skin when applying pressure. The ultra-

sound scanner was equipped with an elastography unit, imageswere presented in a split-screen mode with the conventionalimages on the right, and the translucent color-scale elastogra-phy images were superimposed on the corresponding ultra-

sound image on the left. A square region of interest (ROI)was set for elastography acquisition; the superior margin wasset to include subcutaneous fat, the inferior margin was set

to include pectoral muscle, and the lateral margin was set toinclude more than 5 mm of breast parenchyma adjacent tothe targeted lesion.

2.4. Image interpretation and data management

For each patient the B-mode ultrasound pictures were catego-

rized according to the Breast Imaging Reporting and DataSystem criteria of the American College of Radiology (ACRBIRADS-US) (12).

The elastograms were evaluated using the Tsukuba Elastic-

ity Score, a 5-point strain scale partly corresponding to the BI-RADS classification (Fig. 1).

So far sensitivity and specificity are the highest when a score

between 3 and 4 is established as the cut-off point for themalignancy (3). Therefore, lesions that are categorized as score1 and score 2 are considered benign, and lesions categorized as

score 4 and 5 are suspicious or highly suspicious for cancer.Lesions categorized as score 3 remain particularly unclear,but are more likely to be benign.

Score 1: strain appears in the entire hypoechoic area (theentire lesion is shown in green as in the surrounding normalbreast).

Score 2: strain is not seen in part of the hypoechoic area

(the lesion is shown as a mosaic of green and blue).Score 3: strain appears only in the peripheral areas and notin the center of the hypoechoic area (the center of the lesion

is shown in blue while the peripheral areas in green).Score 4: no strain appears in the entire hypoechoic area (theentire lesion appears in blue).Score 5: no strain appears either in the hypoechoic area or

in surrounding areas (the lesion and surrounding areas areshown in blue).

2.5. Statistical analysis

We used the statistical software package SPSS 17.0 (Chicago,IL, USA). In order to assess the accuracy of real-time tissueelastography compared with the histological results. The diag-nostic sensitivity, specificity and positive and negative predic-

tive values as well as the pretest and posttest probability ofdisease were calculated based on the specimen histology asthe gold standard using Fisher’s exact test. A separate analysis

with respect to BI-RADS-US 3 and 4 tumors was performed.

3. Results

All 410 cases were histologically evaluated. Specimen histologydemonstrated 196 malignant and 214 benign lesions. The his-tological results are summarized in Table 1. The average diam-

eter of benign tumors was 15.8 ± 10.2 mm and 17.0 ± 9.2 mmof malignant tumors. The size difference was not significant(p> 0.05).

Using B-mode ultrasound for the 214 benign lesions, 163were correctly identified, while 51 of these lesions were incor-rectly classified as BI-RADS-US 4 or 5. Using USE, 192 ofthe 214 lesions were correctly classified. Regarding the malig-

nant lesions, B-mode ultrasound yielded a correct classificationof BI-RADS-US 4 or 5 in 186 of 196 cases. USE identified 146lesions as malignant, but the remaining 50 lesions showed a

normal elastogram.The resulting sensitivity for conventional B-mode ultra-

sound was 95.0% and significantly higher than the sensitivity

for USE that was 81.2%. Regarding the specificity, USEyielded the best result with 89.5%, which was significantlyhigher than the specificity in B-mode ultrasound (76.1%).

The positive predictive value was high for USE (86.8%) andthus significantly higher than in conventional ultrasound,which showed a positive predictive value of 77.2%. B-modeultrasound had the best negative predictive value of 94.7%,

which was significantly higher than the negative predictivevalue of USE (84.8%). The results are summarized in Table 2.

3.1. Impact of evaluating BI-RADS-US 3 lesions withsonoelastography

Regarding the 95 lesions that were classified BI-RADS-US 3 in

conventional ultrasound, we obtained the following results:The pretest probability of disease in these cases was 8.3%

and rose significantly to 45.5% with an abnormal elastogram

(Tsukuba Elasticity Score 4 or 5). The posttest probability ofdisease with a normal elastogram (Tsukuba Elasticity Score1 to 3) was only 3.1%, although this difference was not signif-icant. The results are summarized in Table 3.

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Fig. 1 Breast elastography images are divided into the following five imaging patterns (Tsukuba Elasticity Score) compared with the B-

mode hypoechoic lesions.

Table 1 Final pathologic diagnoses in 410 breast lesions.

Malignant lesions (196)

Invasive ductal carcinoma 136

Invasive lobular carcinoma 33

Other invasive carcinoma 20

Ductal carcinoma in situ 7

Benign lesions (214)

Cyst 62

Fibroadenoma 60

Fibrosis 21

Fibrocystic mastopathy 22

Mastitis 8

Papilloma 4

Other benign 37

Table 2 Comparison of sensitivity, specificity, positive (PPV)

and negative predictive value (NPV) for B-mode ultrasound in

the differentiation of benign lesions from malignant breast

cancer. 95% confidence interval in brackets.

B-mode ultrasound Sonoelastography

Sensitivity 95.0 (92.0–97.0) 81.2 (76.7–85.1)

Specificity 76.1 (71.7–80.1) 89.5 (86.1–92.2)

PPV 77.2 (73.0–81.0) 86.8 (82.6–90.2)

NPV 94.7 (91.5–96.7) 84.8 (81.1–88.0)

1024 F.Z. Moukhtar, A.A.A. ElMaati

3.2. Impact of evaluating BI-RADS-US 4 lesions withsonoelastography

We performed the identical test as for the BI-RADS-US 3lesions with respect to the BI-RADS-US 4 lesions (n = 112).

For these lesions we found an initial probability of disease of56.6%, which rose significantly to 81.5% after a positive test,meaning a suspicious elastogram (Tsukuba Elasticity Score 4

or 5). The posttest probability of disease with a normal elasto-gram (Tsukuba Elasticity Score 1–3) was 24.2% and thereforesignificantly lower. The results are summarized in Table 4.

3.3. Evaluating the accuracy of sonoelastography with respect tothe density of the breast

We found no significant differences regarding the sensitivity

and the positive predictive value, which were 84.2% and89.6% in dense breasts ACR III-IV and 84.4% and 91.0%in less dense breasts ACR I-II.

There was a trend toward a higher specificity in densebreasts (92.8%) compared with ACR I-II breasts (82.7%)although this difference was not significant. The negative pre-

dictive value was significantly higher in dense breasts (88.8%)than in less dense breasts (72.0%). The results are summarizedin Table 5.

Five case examples are presented. Fig. 2 shows a partially

mottled low echo on USG lesion with TES of 4. Biopsy

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Table 3 Comparison of pretest and posttest probability of disease (POD) within the subgroup of BI-RADS-US 3 lesions. 95%

confidence interval in brackets.

Tsukuba Elasticity Score 1–3 (test negative) Tsukuba Elasticity Score 4–5 (test positive)

Pretest POD 8.3 (4.9–13.6)

Posttest POD 3.1 (1.1–7.6) 45.5 (25.1–67.3)

Table 4 Comparison of pretest and posttest probability of disease (POD) within the subgroup of BI-RADS-US 4 lesions. 95%

confidence interval in brackets.

Tsukuba Elasticity Score 1–3 (test negative) Tsukuba Elasticity Score 4–5 (test positive)

Pretest POD 56.6 (49.8–63.2)

Posttest POD 24.2 (16.3–34.3) 81.5 (73.3–87.7)

Table 5 Comparison of sensitivity, specificity and positive

(PPV) and negative predictive value (NPV) for sonoelastogra-

phy with respect to the density of the breast. 95% confidence

interval in brackets.

ACR I–II ACR III–IV

Sensitivity 84.4 (77.8–89.4) 84.2 (76.6–89.7)

Specificity 82.7 (72.4–90.0) 92.81 (87.7–95.9)

PPV 91.0 (85.0–94.8) 89.6 (82.6–94.1)

NPV 72.0 (61.6–80.6) 88.82 (83.2–92.8)

Real-time tissue elastography for breast lesion evaluation 1025

result was ductal carcinoma in situ. Fig. 3 shows ductal car-cinoma in situ, diagnosed after repetition of pathology, asits TES was 5. Fig. 4 shows a sclerosing adenosis lesion with

a TES of 3. Fig. 5 shows a case of encephaloid carcinomawith a TES of 4. Lastly, Fig. 6 illustrates an in situ ductalcarcinoma with an invasive component that was interpreted

on US as benign sclerosing adenosis lesion, yet with a TESof 4.

Fig. 2 B-mode US image (A) and USE image (B) performed in a pati

features of a BI-RADS-US 3 lesion. The elastogram (B) shows no str

Score 4. Pathology showed in situ ductal carcinoma.

4. Discussion

Elasticity imaging is based on the premise that there is aninherent difference in the pliability of normal versus diseasedtissue, and this difference can be measured as strain (displace-

ment or elongation of tissue during manual compression) anddisplayed in real time during sonographic imaging (15). Thefirst dynamic tests using real-time ultrasound to assess the

compressibility of breast masses were introduced in the 1980sand have been used ever since (16). Over the years sonoelastog-raphy has evolved gradually from a relatively complicatedmethod involving large and cumbersome hardware and com-

plicated examination set-ups (18,19) to an elegant ultrasound-based technique. Real-time tissue elastography as it is availabletoday is a dynamic method, which is mainly used for the eval-

uation of lesions in breast, prostate or thyroid tissue, axillaryand mediastinal lymph nodes and for the assessment of forcegeneration in skeletal muscle (17–19).

The sensitivity in our study for B-mode ultrasound, regard-ing all BI-RADS-US categories, was 95% and the specificity(76.1%) was rather poor, but this was increased up to 89.5%

ent with fibrocystic dysplasia. The B-mode picture (A) exhibits the

ain over the entire lesion and was categorized Tsukuba Elasticity

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Fig. 3 (A) B-mode US image and (B) USE image performed in a patient with fibrocystic dysplasia revealed a hypoechoic lesion with

irregular boundaries exhibiting the features of a BI-RADS-US 4 lesion. Tsukuba Elasticity Score was 5. Pathology revealed localized

adenosis yet considering the TES of 5 wire localization and excisional biopsy was recommended that revealed in situ ductal carcinoma.

Fig. 4 (A) B-mode US image and (B) USE image reveal an ill defined hypoechoic lesion exhibiting the features of a BI-RADS-US 4

lesion, yet with a Tsukuba Elasticity Score of 3, suggestive of a benign lesion. Biopsy results revealed sclerosing adenosis.

1026 F.Z. Moukhtar, A.A.A. ElMaati

by the use of realtime elastography. The results are compara-ble to those of Sadigh et al. (20) in a recent meta-analysis

regarding all BI-RADS-US categories, where real time elastog-raphy demonstrated a sensitivity of 79% and an excellent spec-ificity of 88% compared to conventional B-mode US (96% and70%, respectively).

There are certain situations in which patients almost neverreceive a single imaging technique alone (i.e. conventionalultrasound, mammography or magnetic resonance imaging),

but usually undergo several different examinations beforereceiving a final diagnosis. Therefore, in a realistic setting,sonoelastography is not applied as a single method but is used

in addition to other examinations in ‘‘heavily pre-diagnosedpatients’’ (21).

An elastogram, for example, might be capable of identify-ing a breast lesion as highly suggestive of malignancy, but if

this lesion was already suspicious on the mammogram (i.e.BI-RADS 5) and/or in the conventional ultrasound (i.e. BI-

RADS-US 5), this additional information would not have aneffect on the management of the patient (21).

Therefore, we need to concentrate on patients and breastlesions where the appropriate action is as yet unclear and amore advanced assessment is needed. This is the rationalefor our focus on patients with BI-RADS - US 3 and BI-RADS

- US 4 lesions. Regarding BI-RADS - US 3 lesions the risk formalignancy is relatively low in this category, but can reach 3%or even more in distinct patient populations (22,13,23).

Our results demonstrate that the majority (91.7%) of BI-RADS-US 3 lesions are in fact benign. In those cases, whichadditionally showed a normal elastogram (Tsukuba Elasticity

Score 1–3), the new negative predictive value was even higherby trend (96.9%). However, as soon as there was a suspiciouselastogram, the risk for a malignant tumor increasedsignificantly from 8.3% to a posttest probability of disease of

45.5%. Our results agreed with a recent study done byWojcinski et al. (21) who were concerned with patients with

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Fig. 5 (A) B-mode US image and (B) USE image showed a hypoechoic circumscribed lesion exhibiting the features of a BI-RADS-US 3

lesion, displaying a mosaic pattern of green and blue but because the blue area is clearly larger the elasticity score was determined to be 4.

Biopsy revealed encephaloid carcinoma.

Fig. 6 (A) B-mode US image and (B) USE image revealed a small, hypoechoic rather ill defined lesion which was interpreted as

sclerosing adenosis, with a Tsukuba Elasticity Score of 4. Pathology revealed in situ ductal carcinoma with invasive component.

Real-time tissue elastography for breast lesion evaluation 1027

a sonographically visible lesion categorized as BI-RADS-US 3.

They demonstrated that the pretest POD was 4.5% and rosesignificantly to 13.2% with a suspicious elastogram in thehigh-risk group.

If biopsy would be taken in these cases, we can estimate a

maximal malignant/benign ratio of 1:3, which means that wecan expect at least 1 carcinoma per 4 biopsies. Regarding thehigh posttest probability of disease, we encourage immediate

histological verification of BI-RADS-US 3 lesions exhibitinga suspicious elastogram (Tsukuba Elasticity Score 4 or 5).

Lesions in BI-RADS US 4 category require histological

verification. If there is no evidence of malignancy in specimenhistology, no further steps are required. This approach impli-cates the risks that are associated with a false negative biopsy.

The pretest probability of disease for BI-RADS-US 4 lesionsin our study was 56.6%. Our results showed a significantlyreduced posttest probability of disease of 24.2% for BI-RADS-US 4 lesions with a normal elastogram (Tsukuba Elas-

ticity Score 1–3) and a significantly increased risk of 81.5% for

lesions with a suspicious elastogram (Tsukuba Elasticity Score4 or 5). Regarding the still high probability of disease after anormal elastogram, there should be no change in the clinicalprocedure in those cases. On the other hand, a suspicious elas-

togram indicates a highly increased risk for a malignant dis-ease. Therefore, we suggest re-biopsy whenever there is a BI-RADS-US 4 lesion with a suspicious elastogram (Tsukuba

Elasticity Score 4 or 5) but the specimen histology shows nomalignancy since a false negative histological result is a possi-ble scenario.

When comparing the results for sonoelastography withrespect to the density of the breast, we found no differenceregarding the identification of malignant lesions, but the nega-

tive predictive value and the specificity were higher in the ACRIII–IV breasts than in ACR I–II breasts. This observation canbe explained by the mechanical principles of sonoelastography:Real-time tissue elastography provides a relative measurement

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1028 F.Z. Moukhtar, A.A.A. ElMaati

of the elasticity of the tissue by comparing the different struc-tures within the region of interest. So far, an absolute measure-ment is not available. Benign lesions usually present soft in

sonoelastography. As the measurement of the lesion is onlyperformed in relation to the surrounding tissue, even a benignlesion might appear relatively hard, if the adjacent tissue is rel-

atively soft (24). Our results in this aspect agree with the modelof an ‘‘elastographic contrast’’ that has been described by Woj-cinski et al. (25) who stated that the ‘‘elastographic contrast’’

for benign lesions seems to be better in hard, which meansdense, breast tissue. Consequently, the correct identificationof benign lesions in a less dense breast seems to be more diffi-cult with sonoelastography.

5. Conclusion

Our study demonstrates that there are no data that indicate aclinical advantage for the additional sonoelastographic evalu-ation of lesions that are categorized BI-RADS-US 0, 1, 2 or5 in conventional ultrasound. However, for lesions that are

categorized BI-RADS-US 3 or 4 in B-mode ultrasound ourdata provide evidence that an improved diagnostic perfor-mance can be achieved by adding real-time tissue elastography.

Conflict of interest

We have no conflict of interest to declare.

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