FOI 241 1011 document 2 - Therapeutic Goods Administration · 2014. 8. 8. · 2 subcutaneous...

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SAFE J . 0 BREAST IMAGING P LTO \ \\�)\ Ultrasound example of 73 yo with malignant tumour in left breast at 12 oclock. 19x20x16 mm irregular shape blurred contours hypoechoic patchy structure hyperechoic inclusions of various dimensions acoustic shadow MEM example of same 73 yo showing malignant tumour at 12 oclock down three layers of scanning ©Safe Breast lmaging Ply Ltd 2009 v.safebreastimaqing.com.au

Transcript of FOI 241 1011 document 2 - Therapeutic Goods Administration · 2014. 8. 8. · 2 subcutaneous...

Page 1: FOI 241 1011 document 2 - Therapeutic Goods Administration · 2014. 8. 8. · 2 subcutaneous adipose tissue 3 superficial fascia, 4 lacteal ducts 5 glandular tissue 6 Cooper ligaments

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BREAST IMAGING PTY L TO \ \\�)\

Ultrasound example of 73 yo with malignant tumour in left breast at 12 oclock.

19x20x16 mm

• irregular shape

• blurred contours

• hypoechoic patchy structure

• hyperechoic inclusions of various dimensions

• acoustic shadow

MEM example of same 73 yo showing malignant tumour at 12 oclock down three layers of scanning

©Safe Breast lmaging Ply Ltd 2009

wwvv.safebreastimaqing.com.au

Page 2: FOI 241 1011 document 2 - Therapeutic Goods Administration · 2014. 8. 8. · 2 subcutaneous adipose tissue 3 superficial fascia, 4 lacteal ducts 5 glandular tissue 6 Cooper ligaments

SAFE BREAST IMAGING PTY L TO

MEM analytical tools showing malignant tumour at 12 oclock in left breast of

73yo woman

0.10

0eau lliC:t:.a nM 18 llitT 50

r 1 ... 2 r 3

,.. 4 ,.. 5 ,.. 6 ,.. 7

Mean electrical conductivity of the left

breast is 0.58, which corresponds to the

age norm.

Electroconductivity in the zone of the

malignant tumour location is 0.96.

0.10 0.60

0.17 0.68 0.39

1.10

64.6419 1.0000 0.10 1.10 0.10 0.60 .

eoaSI ne»:a nM 18 neT 50 �r-e-•• -

•• -

e.-a�OM�1�8-.e�r5�0------

© Safe Breast lmaging Ply Ltd 2009

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1300 310 820

Page 3: FOI 241 1011 document 2 - Therapeutic Goods Administration · 2014. 8. 8. · 2 subcutaneous adipose tissue 3 superficial fascia, 4 lacteal ducts 5 glandular tissue 6 Cooper ligaments

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SAFE BREAST IMAGING PTV L TO

Ultrasound example of 39 yo with cyst in right breast at 10 oclock

CpeAHee : 0. 46 C.K.O. :0.1100 MHH : 0.16 MaKe : 0.84

,!J.HarpaMMa npoBOAHMOCTI1

CpeAHee : 0, 77

© Safe Breast lmaging Pty Ltd 2009

www.safebreastimaqinq.com.au

oval form

absence of reflection from internal

contents

distal enchantment

well-defined differentiation

between internal and external

contours

bright posterior wall

symmetrical lateral acoustic

Oval shape of cyst, "onion"

layers of conductivity

surrounding the cyst.

Electroconductivity of the cyst

is 0.77 against background

mean electroconductivity of

0.46, which corresponds to the

age group in the norm

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Example of 33yo with fibroadenoma in left breast.

3 1 nattHtHJ 2 133 a

CpeAHee : 0.65 C.K.O. : 0.0631 MHH : 0.49 M;urr • n 7R

©Safe Breast lmaging Pty Ltd 2009

www.safebreastimaqing.com.au

• oval shape

• well-defined hyperechoic contours

• hypoechoic heterogeneous structure

• hyperechoic inclusions of various dimensions

• distal pseudou-enhancement behind the

fibroadenoma.

Electroconductivity of the

Fibroadenoma 0,65 against

background of mean

electroconductivity of 0,48, which

corresponds to the age norm.

1300 310 820

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Page 5: FOI 241 1011 document 2 - Therapeutic Goods Administration · 2014. 8. 8. · 2 subcutaneous adipose tissue 3 superficial fascia, 4 lacteal ducts 5 glandular tissue 6 Cooper ligaments

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SAFE BREAST IMAGING PTY L TO

Breast Structure

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1 skin

2 subcutaneous adipose tissue

3 superficial fascia,

4 lacteal ducts 5 glandular tissue

6 Cooper ligaments

7 pectoral muscles

8 ribs

9 nipple

10 Duret crest

11 retromammary adipose bursa

12 perinipple muscle

13 lacteal sinus

14 posterior folium of the pectoral

fascia

A Lacteal ducts Level 1

B Lacteal ducts Level 2

C Lacteal ducts Level 3

Page 6: FOI 241 1011 document 2 - Therapeutic Goods Administration · 2014. 8. 8. · 2 subcutaneous adipose tissue 3 superficial fascia, 4 lacteal ducts 5 glandular tissue 6 Cooper ligaments

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SAFE BREAST IMAGING PTY L TO

Electrical impedance anatomy of the breast

© Safe Breast lmaging Pty Ltd 2009 www.safebreastimaqinq.com.au

The first scanning level (depth 4mm) Subcutaneous adipose tissue

Superficial fascia (anterior folium of the pectoral fascia)

Lacteal sinus

Cooper ligament

Glandular tissue (fibro-glandular complex)

The second scanning level (depth 11mm)

Subcutaneous adipose tissue

Superficial fascia (anterior folium of the pectoral fascia)

Lacteal sinus

Cooper ligaments

Glandular tissue (fibro-glandular complex)

The third scanning level (depth 18mm) Subcutaneous adipose tissue

I· lnlralobular adipose tissue

1 Cooper ligaments

Glandular tissue (fibro-glandular complex)

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SAFE BREAST IMAGING PTY L TO

© Safe Breast lmaging Pty Ltd 2009 W'NIN.safebreastimaqinq.com.au

Image of right breast of healthy 43yo {Slide 1)

Second phase of menstrual cycle.

7 layers, each 7mm apart down to

46mm.

al anatomical structure.

Fatty lipoma at second and third level

(very low conductivity).

Adipose tissue surrounding nipple (Low

Retromammary adipose tissue.

Reimage annually.

Image of right breast of healthy 43yo (Slide 2)

Analytical tool in two frames to compare

right and left breast to each other, and

breast compared to a normal database.

Comparative analysis of left and right

breast shows symmetrical and low

conductivity, suggesting slight fibrous

mastopathy.

No excess oestrogen.

Reimage annually.

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SAFE BREAST IMAGING PTY L TO

© Safe Breast lmaging Pty Ltd 2009 wvvvv.safebreastimaging.com.au

Example of healthy 25yo, day 6 of menstrual cycle

Normal level of high conductivity at

nipple area, down to 2 levels.

Conductivity is small, circular and

symmetrical in each breast.

Reimage annually.

Example of 56yo, post-menopause 4 years with fibrous mastopathy

Symmetrical conductivity in each breast.

Lower than comparison to the norm for

age group in conductivity.

Slight fibrous mastopathy.

Reimage annually.

Example of 71yo, post-menopause 15 years with suspicious mass (Slide 1)

Contour of right breast distorted.

Distortion of structure down 4 levels (to

25mm).

High conductivity (highlighted in red)

down 3 levels in right breast.

Excess glandular tissue for age.

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SAFE BREAST IMAGING PTV L TO

© Safe Breast lmaging Pty Ltd 2009 IN'NW.safebreastimaging.com.au

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Example of 71yo, post-menopause 15 years with suspicious mass (Slide 2)

Comparison right and left breast.

Right breast in green, left breast in

yellow.

Right breast higher conductivity than

left, and irregular histogram shape.

Average conductivity of right breast is

0.64, compared to 0.45 for left.

Refer to own doctor for clinical

examination and further investigation.

Reimage in 3 months.

Example of 61 yo, post-menopause 3 years with cancer

Dense fibroglandular breasts

Large area of glandular tissue in right

breast

Conductivity significantly higher to the

normal database

Cancer at 10 o'clock, Right breast

2cm from nipple, 2cm x 1. 25cm

Refer to own doctor for clinical

examination and further investigation.

Example of 45 yo with lumpy left breast and multiple cysts.

Hysterectomy at 33.

Images show cysts circled in red.

Distortion of outline of the breast due to

lumpiness.

Fatty lobules shown in black (low

conductivity).

Increased breast cancer risk and should

be monitored regularly.

Reimage in 6 months.

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