Imaging Diagnostic Systems (fka IMDS)

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The CTLM is NOT approved for sale in Australia

The Australian TGA cancelled IMDS's approval to sell the CTLM in the country after a scathing article was written by the Cancer Council of western Australia

http://www.breastscreen.health.wa.gov.au/docs/Unproven-Breast-Imaging-Factsheet.pdf

this is an Australian Government website
Unproven breast imaging technologies – the facts
Unproven breast imaging technologies are aggressively marketed in Western Australia, particularly to young
women. They are often promoted as an alternative to mammography, the screening tool for breast cancer.
This factsheet provides information about the unproven breast imaging technologies that are commercially
available in Western Australia. These include:
? Electrical impedance
? Computerised/mechanical breast imaging (CBI)
? Thermography
? Computed Tomography Laser Mammography (CTLM)
Concerns
The promotion of unproven breast imaging technologies has raised concerns among health professionals and
cancer experts, as there is little or no scientific evidence to demonstrate that these technologies reduce
deaths from breast cancer.
In fact, none of these technologies are approved for use in Australia as stand alone tests for breast cancer
detection – they are only approved for use in conjunction with scientifically proven breast imaging
techniques such as mammography.
Breast imaging technologies are commercially available because they have been approved for use by the
Therapeutic Goods Administration (TGA). However, this approval only ensures that the technologies are
safe in terms of immediate harm. Therapeutic Goods Administration approval does not mean that the
technologies can detect breast cancer or should be used as screening tools.
Screening with mammography
Screening is an organised program in which well people are invited to be tested for signs of a disease in
its early stages, or before it develops symptoms. Screening does not diagnose the disease but identifies
people who need to undergo further tests to determine whether the disease is present. Regular
screening mammograms have been proven to reduce the number of breast cancer deaths.
BreastScreen WA offers women free mammograms (breast x-rays) to screen women for breast cancer.
Women aged 50-69 are invited to attend, and women aged 40-49 and 70+ years are also eligible to
attend. BreastScreen WA is rigorously audited to ensure the safety and quality of its service. The
operators offering unproven breast imaging commercially are not subject to any audit or quality control
measures to ensure they deliver their services in a safe manner.

Computer Tomography Laser Mammography (CTLM)
Computed tomography laser mammography (CTLM) sends near infrared light into breast tissue. Near infrared light is
absorbed by haemoglobins (proteins) in the blood, which act as a contrast medium. The CTLM device is claimed to
detect increased blood vessel formation in tissue, which is a feature of tumours.
CTLM is a new technology that does not appear to have been clinically evaluated as a stand alone test for breast
cancer detection. The existing evidence reveals major limitations with the low resolution of CTLM images, and
indicates CTLM requires considerably further development and evaluation.
There do not appear to be any clinics offering CTLM technology yet in Western Australia, however the Australasian
distributor for CTLM is based in Perth.
Summary
It is vital that women understand that the unproven breast imaging technologies featured in this fact sheet are not
proven to effectively detect or screen for breast cancer. Research does not confirm that any of the technologies
are valid alternatives to mammographic screening, and clinical decisions cannot be based on the results of these
unproven imaging tests. Women with a lump detected using an unproven breast imaging device will still require
assessment using conventional, validated methods, such as mammography or breast ultrasound, for a definitive
diagnosis.
Of the range of techniques in use for the detection of breast cancer, mammography is currently the only
examination that is supported by objective and randomised clinical trials for screening and diagnosis. To book your
mammogram appointment with BreastScreen WA phone 13 20 50 (cost of a local call). For more information about
the BreastScreen WA program visit: www.breastscreen.health.wa.gov.au
All women should be aware of the look and feel of their breasts. If they notice any change in their
breasts, such as a lump, redness, pain, puckering of the skin or nipple discharge, they should contact their
doctor promptly to arrange furt