Title: THREEDIMENSIONAL I'T'M BREAST IMAGING SYSTEM
1THREE-DIMENSIONAL I.T.M BREAST IMAGING SYSTEM
- Technology, benefits and current development
2INDICATIONS FOR USE
In Gynecology The ITM is intended for use as
early detection of mammary gland pathologies
Possibility to examine teenagers, women of any
age, pregnant and breast-feeding women it allows
diagnosis of mastopathy, mastitis, evaluating
lactation function as well as monitoring the
state of the breasts during mastopathy treatment.
In Oncology The ITM is intended for use as an
adjunct to mammography in patients who have
equivocal mammographic findings within ACR
BI-RADSTM categories 3 or 4. In particular, it is
not intended for use in cases with clear
mammographic or nonmammographic indications for
biopsy. This device provides the radiologist with
additional information to guide a biopsy
recommendation.
The device is intended for use on women age gt 20
years old. The system will be use by licensed
practitioner and the interpretation will be made
by radiologists who have satisfactorily completed
the training phase of the ITM system.
3HISTORY
Tran Scan RD Co., Siemens 1996-2003
conductivity mapping (T-Scan)
T. Kerner, K. Paulsen, A. Hartov et al,
2000-2003 2D EIT
R. Skidmore, J. Evans, D. Jenkins and P. Wells,
1987 2D EIT
16 electrodes, multi-frequency measurements,
preliminary clinical study
16 electrodes data collection system, no
clinical results
FDA approved in 1999, multi-center clinical trials
4ITM measuring equipment for 3D imaging
1 electrodes array 2 remote electrodes (R.E.)
5Data acquisition sequence
Connect first matrix electrode to voltmeter
Connect first matrix electrode to current source
Inject current and make measurement
Last electrode for injecting?
No
Connect next matrix electrode to current source
Yes
Last electrode for measuring?
Connect next matrix electrode to voltmeter
No
Result is 65536 16 bit integer values (voltages)
Yes
End of measurements
6Reconstruction
Electrical impedance tomography with planar array
enables imaging of three-dimensional distribution
of electrical conductivity in subsurface areas (
5-cm depth) using flat matrix of 256 electrodes.
For the convenience of viewing, the results are
represented as the set of cross-sections (slices).
7Calculation of the electric field intensity
1. Finite-difference approximation on staggered
grids
x1
2. Two-dimensional linear interpolation of each
component
y2
electrodes
grid, where Ex is defined
grid, where Ey is defined
position inside corresponding grid cell
8Clinical tests
9In vivo images example
Carcinoma (right breast)
Norm (left breast)
10How does this surpass the T-Scan technology?
Image quality is rigidly limited in T-Scan by the
physics of the current flow. The collected data
set is poor and no data processing is
applicable. In ITM system there are no hard
limitations of image quality. The number of
electrodes, accuracy of measurements and
complexity of reconstruction algorithm are
limiting factors. The collected data set is full
for given geometry of electrodes.
11Integral view
ITM software enables imaging in Integral view
Yellow points denote bad contacts
12Why the ITM imaging
The electro conductivity of the tissue is very
sensitive to the cancer
In adjunct to mammography in patients who have
equivocal mammographic findings within ACR
BI-RADSTM categories 3 or 4 , the ITM provides
the radiologist with additional information to
guide a biopsy recommendation. And increased the
sensivity of the breast cancer to 85 .