Imaging Diagnostic Systems (fka IMDS)

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TGA approval was cancelled for IMDS and the CTLM cannot be sold in Australia

Cancer Council of western Australia informed the public December of 2010 the CTLM is "unproven" and women should not rely on it as a stand alone test for breast cancer.

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

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.

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.


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.

The CTLM is NOT approved for sale in Australia. IMDS own distributor confirms this on their website

www.shimadzumedical.com.au/products/ctlaserbreastimaging.html

Not included on the Australian Register of Therapeutic Goods and currently not for sale.