We have investigated the development of a handheld 4 × 1 piezoelectric finger (PEF) array breast tumor detector system towards in vivo patient testing, particularly, on how the duration of the DC applied voltage, the depression depth of the handheld unit, and breast density affect the PEF detection sensitivity on 40 patients. The tests were blinded and carried out in four phases: with DC voltage durations 5, 3, 2, to 0.8 s corresponding to scanning a quadrant, a half, a whole breast, and both breasts within 30 min, respectively. The results showed that PEF detection sensitivity was unaffected by shortening the applied voltage duration from 5 to 0.8 s nor was it affected by increasing the depression depth from 2 to 6 mm. Over the 40 patients, PEF detected 46 of the 48 lesions (46/48)—with the smallest lesion detected being 5 mm in size. Of 28 patients (some have more than one lesion) with mammography records, PEF detected 31/33 of all lesions (94%) and 14/15 of malignant lesions (93%), while mammography detected 30/33 of all lesions (91%) and 12/15 of malignant lesions (80%), indicating that PEF could detect malignant lesions not detectable by mammography without significantly increasing false positives. PEF’s detection sensitivity is also shown to be independent of breast density, suggesting that PEF could be a potential tool for detecting breast cancer in young women and women with dense breasts.
REFERENCES
1.
A. C. Society
, Cancer Facts and Figures, available: http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf, 2015
.2.
W. H. Organization
, Breast Cancer: Prevention and Control, available: http://www.who.int/cancer/detection/breastcancer/en/index.html, 2011
.3.
W. H.
Goodson
III, N. A.
Grissom
, D. H.
Moore
II, and F. M.
Dirbas
, “Streamlining clinical breast examination
,” JNCI, J. Natl. Cancer Inst.
97
, 1476
–1477
(2005
).4.
P.
Weatherall
, G. F.
Evans
, G. J.
Metzger
, M. H.
Saborrian
, and A. M.
Leitch
, “MRI vs. histologic measurement of breast cancer following chemotherapy: Comparison with x-ray mammography and palpation
,” J. Magn. Reson. Imaging
13
, 868
–875
(2001
).5.
I.
Mittra
, M.
Baum
, H.
Thornton
, and J.
Houghton
, “Is clinical breast examination an acceptable alternative to mammographic screening?
,” BMJ
321
, 1071
–1073
(2000
).6.
T. M.
Kolb
, J.
Lichy
, and J. H.
Newhouse
, “Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: An analysis of 27825 patient evaluations
,” Radiology
225
, 165
–175
(2002
).7.
P.
Crystal
, S. D.
Strano
, S.
Shcharynski
, and M. J.
Koretz
, “Using sonography to screen women with mammographically dense breasts
,” Am. J. Roentgenol.
181
, 177
–182
(2003
).8.
S. S.
Kaplan
, “Clinical utility of bilateral whole-breast US in the evaluation of women with dense breast tissue
,” Radiology
221
, 641
–649
(2001
).9.
P. A.
Carney
, D. L.
Miglioretti
, B. C.
Yankaskas
, K.
Kerlikowske
, R.
Rosenberg
, C. M.
Rutter
et al., “Individual and combined effects of age, breast density, and hormone replacement therapy use on the accuracy of screening mammography
,” Ann. Intern. Med.
138
, 168
–175
(2003
).10.
C. M.
Checka
, J. E.
Chun
, F. R.
Schnabel
, J.
Lee
, and H.
Toth
, “The relationship of mammographic density and age: Implications for breast cancer screening
,” Am. J. Roentgenol.
198
, W292
–W295
(2012
).11.
M. S.
Soo
, J. A.
Baker
, and E. L.
Rosen
, “Sonographic detection and sonographically guided biopsy of breast microcalcifications
,” Am. J. Roentgenol.
180
, 941
–948
(2003
).12.
C. K.
Kuhl
, S.
Schrading
, C. C.
Leutner
, N.
Morakkabati-Spitz
, E.
Wardelmann
, R.
Fimmers
et al., “Mammography, breast ultrasound, and magnetic resonance imaging for surveillance of women at high familial risk for breast cancer
,” J. Clin. Oncol.
23
, 8469
–8476
(2005
).13.
M. S.
Richards
, P. E.
Barbone
, and A. A.
Oberai
, “Quantitative three-dimensional elasticity imaging from quasi-static deformation: A phantom study
,” Phys. Med. Biol.
54
, 757
(2009
).14.
S. H.
Heywang-Koebrunner
and I.
Schreer
, Diagnostic Breast Imaging: Mammography, Sonography, Magnetic Resonance Imaging, and Interventional Procedures
(Thieme
, 2014
).15.
C. D.
Lehman
, C.
Gatsonis
, C. K.
Kuhl
, R. E.
Hendrick
, E. D.
Pisano
, L.
Hanna
et al., “MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer
,” N. Engl. J. Med.
356
, 1295
–1303
(2007
).16.
R. F.
Brem
, M.
Fishman
, and J. A.
Rapelyea
, “Detection of ductal carcinoma in situ with mammography, breast specific gamma imaging, and magnetic resonance imaging: A comparative study
,” Acad. Radiol.
14
, 945
–950
(2007
).17.
R. F.
Brem
, M.
Ioffe
, J. A.
Rapelyea
, K. G.
Yost
, J. M.
Weigert
, M. L.
Bertrand
et al., “Invasive lobular carcinoma: Detection with mammography, sonography, MRI, and breast-specific gamma imaging
,” Am. J. Roentgenol.
192
, 379
–383
(2009
).18.
Imaginis
, Scientists Find Mammography is Still “Gold Standard” for Breast Cancer Detection but Recommend Research into More Accurate Methods, available: http://imaginis.com/breasthealth/news/news3.14.01.asp, 2001
.19.
B. L.
Sprague
, R. E.
Gangnon
, V.
Burt
, A.
Trentham-Dietz
, J. M.
Hampton
, R. D.
Wellman
et al., “Prevalence of mammographically dense breasts in the United States
,” JNCI, J. Natl. Cancer Inst.
106
, dju255
(2014
).20.
H.
Zhi
, B.
Ou
, B.-M.
Luo
, X.
Feng
, Y.-L.
Wen
, and H.-Y.
Yang
, “Comparison of ultrasound elastography, mammography, and sonography in the diagnosis of solid breast lesions
,” J. Ultrasound Med.
26
(6
), 807
–815
(2007
).21.
C. S.
Huang
, K. J.
Chang
, and C. Y.
Shen
, “Breast cancer screening in Taiwan and China
,” Breast Dis.
13
, 41
–48
(2001
).22.
N. F.
Boyd
, H.
Guo
, L. J.
Martin
, L.
Sun
, J.
Stone
, E.
Fishell
et al., “Mammographic density and the risk and detection of breast cancer
,” N. Engl. J. Med.
356
, 227
–236
(2007
).23.
N. F.
Boyd
, J. M.
Rommens
, K.
Vogt
, V.
Lee
, J. L.
Hopper
, M. J.
Yaffe
et al., “Mammographic breast density as an intermediate phenotype for breast cancer
,” Lancet Oncol.
6
, 798
–808
(2005
).24.
O.
Ginsburg
, L.
Martin
, and N.
Boyd
, “Mammographic density, lobular involution, and risk of breast cancer
,” Br. J. Cancer
99
, 1369
–1374
(2008
).25.
R. M.
Tamimi
, C.
Byrne
, G. A.
Colditz
, and S. E.
Hankinson
, “Endogenous hormone levels, mammographic density, and subsequent risk of breast cancer in postmenopausal women
,” J. Natl. Cancer Inst.
99
, 1178
–1187
(2007
).26.
N.
Boyd
, J.
Byng
, R.
Jong
, E.
Fishell
, L.
Little
, A.
Miller
et al., “Quantitative classification of mammographic densities and breast cancer risk: Results from the Canadian national breast screening study
,” J. Natl. Cancer Inst.
87
, 670
–675
(1995
).27.
L.
Yaghjyan
, G. A.
Colditz
, B.
Rosner
, and R. M.
Tamimi
, “Mammographic breast density and breast cancer risk: Interactions of percent density, absolute dense, and non-dense areas with breast cancer risk factors
,” Breast Cancer Res. Treat.
150
, 181
–189
(2015
).28.
J.
Peres
, “Little progress in how to advise women with dense breasts
,” J. Natl. Cancer Inst.
107
, djv266
(2015
).29.
W. A.
Berg
, J. D.
Blume
, J. B.
Cormack
, E. B.
Mendelson
, D.
Lehrer
, M.
Böhm-Vélez
et al., “Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer
,” JAMA
299
, 2151
–2163
(2008
).30.
R. F.
Brem
, L.
Tabár
, S. W.
Duffy
, M. F.
Inciardi
, J. A.
Guingrich
, B. E.
Hashimoto
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
274
, 663
–673
(2014
).31.
O.
Mokhtar
and S.
Mahmoud
, “Can contrast enhanced mammography solve the problem of dense breast lesions?
,” Egypt. J. Radiol. Nucl. Med.
45
, 1043
–1052
(2014
).32.
C. R.
Jeukens
, U. C.
Lalji
, E.
Meijer
, B.
Bakija
, R.
Theunissen
, J. E.
Wildberger
et al., “Radiation exposure of contrast-enhanced spectral mammography compared with full-field digital mammography
,” Invest. Radiol.
49
, 659
–665
(2014
).33.
B. S.
Garra
, E. I.
Cespedes
, J.
Ophir
, S. R.
Spratt
, R. A.
Zuurbier
, C. M.
Magnant
et al., “Elastography of breast lesions: Initial clinical results
,” Radiology
202
, 79
–86
(1997
).34.
A. L.
McKnight
, J. L.
Kugel
, P. J.
Rossman
, A.
Manduca
, L. C.
Hartmann
, and R. L.
Ehman
, “MR elastography of breast cancer: Preliminary results
,” Am. J. Roentgenol.
178
, 1411
–1417
(2002
).35.
T. A.
Krouskop
, T. M.
Wheeler
, F.
Kallel
, B. S.
Garra
, and T.
Hall
, “Elastic moduli of breast and prostate tissues under compression
,” Ultrason. Imaging
20
, 260
–274
(1998
).36.
A.
Samani
and D.
Plewes
, “An inverse problem solution for measuring the elastic modulus of intact ex vivo breast tissue tumours
,” Phys. Med. Biol.
52
, 1247
–1260
(2007
).37.
A.
Samani
, J.
Zubovits
, and D.
Plewes
, “Elastic moduli of normal and pathological human breast tissues: An inversion-technique-based investigation of 169 samples
,” Phys. Med. Biol.
52
, 1565
(2007
).38.
A.
Sarvazyan
, “Mechanical imaging: A new technology for medical diagnostics
,” Int. J. Med. Inf.
49
, 195
–216
(1998
).39.
V.
Egorov
and A. P.
Sarvazyan
, “Mechanical imaging of the breast
,” IEEE Trans. Med. Imaging
27
, 1275
–1287
(2008
).40.
V.
Egorov
, T.
Kearney
, S. B.
Pollak
, C.
Rohatgi
, N.
Sarvazyan
, S.
Airapetian
et al., “Differentiation of benign and malignant breast lesions by mechanical imaging
,” Breast Cancer Res. Treat.
118
, 67
–80
(2009
).41.
P. L.
Yen
, D. R.
Chen
, K. T.
Yeh
, and P. Y.
Chu
, “Lateral exploration strategy for differentiating the stiffness ratio of an inclusion in soft tissue
,” Med. Eng. Phys.
30
, 1013
–1019
(2008
).42.
D. O.
Uribe
, R.
Stroop
, and J.
Wallaschek
, “Piezoelectric self-sensing system for tactile intraoperative brain tumor delineation in neurosurgery
,” in 31st Annual International Conference of the IEEE EMBS
, Minneapolis, Minnesota, USA
(IEEE
, 2009
), pp. 737
–740
.43.
D. O.
Uribe
, R.
Stroop
, T.
Hemsel
, and J.
Wallaschek
, “Development of a biomedical tissue differentiation system using piezoelectric actuators
,” in 2008 IEEE International Frequency Control Symposium
(2008
), pp. 91
–94
.44.
H. O.
Yegingil
, W. Y.
Shih
, W.
Anjum
, A. D.
Brooks
, and W. H.
Shih
, “Soft tissue elastic modulus measurement and tumor detection using piezoelectric fingers
,” Mater. Res. Soc. Symp. Proc.
898
, 1
–6
(2006
).45.
H. O.
Yegingil
, Breast Cancer Detection and Differentiation Using Piezoelectric Fingers
(Drexel University
, 2009
).46.
E. J.
Chen
, J.
Novakofski
, W. K.
Jenkins
, and W. D.
O’Brien
, “Young’s modulus measurements of soft tissues with application to elasticity imaging
,” IEEE Trans. Ultrason. Eng.
43
, 191
–194
(1996
).47.
J.-H.
Lee
and C.-H.
Won
, “High resolution tactile imaging sensor using total internal reflection and non-rigid pattern matching algorithm
,” IEEE Sens. J.
11
(9
), 2084
(2011
).48.
J. H.
Lee
and C. H.
Won
, “Inclusion mechanical property estimation using tactile images, finite element method, and artificial neural network
,” in Annual International Conference of the IEEE
(IEEE
, 2011
), pp. 14
–17
.49.
J.
Ophir
, I.
Cespedes
, H.
Ponnekanti
, Y.
Yazdi
, and X.
Li
, “Elastography: A quantitative method for imaging the elasticity of biological tissues
,” Ultrason. Imaging
13
, 111
–134
(1991
).50.
J.
Ophir
, I.
Cespedes
, B.
Garra
, H.
Ponnekanti
, Y.
Huang
, and N.
Maklad
, “Elastography: Ultrasonic imaging of tissue strain and elastic modulus in vivo
,” Eur. J. Ultrasound
3
, 49
–70
(1996
).51.
K. M.
Hiltawsky
, M.
Krüger
, C.
Starke
, L.
Heuser
, H.
Ermert
, and A.
Jensen
, “Freehand ultrasound elastography of breast lesions: Clinical results
,” Ultrasound Med. Biol.
27
, 1461
(2001
).52.
A.
Thomas
, T.
Fischer
, H.
Frey
, R.
Ohlinger
, S.
Grunwald
, J. U.
Blohmer
et al., “Real-time elastography—An advanced method of ultrasound: First results in 108 patients with breast lesions
,” Ultrasound Obstet. Gynecol.
28
, 335
–340
(2006
).53.
H.
Yegingil
, W. Y.
Shih
, and W. H.
Shih
, “Probing elastic modulus and depth of bottom-supported inclusions in model tissues using piezoelectric cantilevers
,” Rev. Sci. Instrum.
78
, 115101
(2007
).54.
H.
Yegingil
, W. Y.
Shih
, and W. H.
Shih
, “All-electrical indentation shear modulus and elastic modulus measurement using a piezoelectric cantilever with a tip
,” J. Appl. Phys.
101
, 054510
(2007
).55.
A.
Markidou
, W. Y.
Shih
, and W. H.
Shih
, “Soft-materials elastic and shear moduli measurement using piezoelectric cantilevers
,” Rev. Sci. Instrum.
76
, 064302
(2005
).56.
S. T.
Szewczyk
, W. Y.
Shih
, and W. H.
Shih
, “Palpationlike soft-material elastic modulus measurement using piezoelectric cantilevers
,” Rev. Sci. Instrum.
77
, 044302
(2006
).57.
S. T.
Szewczyk
and W.-H.
Shih
, “Exploring all-electrical soft-tissue stiffness measurement using piezoelectric unimorph cantilevers
,” in IEEE 29th Annual, Proceedings of Bioengineering Conference
(IEEE
, 2003
), pp. 146
–147
.58.
S. E.
Duenwald
, R.
Vanderby
, and R. S.
Lakes
, “Stress relaxation and recovery in tendon and ligament: Experiment and modeling
,” Biorheology
47
(1
), 1
–4
(2010
).59.
S. E.
Duenwald
, R.
Vanderby
, and R. S.
Lakes
, “Viscoelastic relaxation and recovery of tendon
,” Ann. Biomed. Eng.
37
, 1131
–1140
(2009
).60.
T. J.
Hall
, M.
Bilgen
, M. F.
Insana
, and T. A.
Krouskop
, “Phantom materials for elastography
,” IEEE Trans. Ultrason. Eng.
44
, 1355
–1365
(1997
).61.
S.
Kalyanam
, R. D.
Yapp
, and M. F.
Insana
, “Poro-viscoelastic behavior of gelatin hydrogels under compression-implications for bioelasticity imaging
,” J. Biomech. Eng.
131
, 081005
(2009
).62.
H.
Mehrabian
, G.
Campbell
, and A.
Samani
, “A constrained reconstruction technique of hyperelasticity parameters for breast cancer assessment
,” Phys. Med. Biol.
55
, 7489
(2010
).63.
J. J.
O’Hagan
and A.
Samani
, “Measurement of the hyperelastic properties of 44 pathological ex vivo breast tissue samples
,” Phys. Med. Biol.
54
, 2557
(2009
).64.
J. J.
O’Hagan
and A.
Samani
, “Measurement of the hyperelastic properties of tissue slices with tumour inclusion
,” Phys. Med. Biol.
53
, 7087
(2008
).65.
X.
Xu
, C.
Gifford-Hollingsworth
, R.
Sensenig
, W. H.
Shih
, W. Y.
Shih
, and A. D.
Brooks
, “Breast tumor detection using piezoelectric fingers: First clinical report
,” J. Am. Coll. Surg.
216
, 1168
–1173
(2013
).© 2016 Author(s).
2016
Author(s)
You do not currently have access to this content.
