Optical Imaging May Improve Breast Cancer Detection

SoftScan® is an optical imaging device designed to improve the detection and diagnosis of breast cancer by providing information additional to x-ray mammography.

How it works

A scan with the SoftScan® optical breast imaging system takes about 15 minutes.

Photo courtesy of ART Advanced Research Technologies Inc.

SoftScan uses near-infrared light to obtain an image of the breast. A laser sends brief pulses of light into the breast at four different wavelengths. Five detectors capture information from the energy that is transmitted through to the other side of the breast. This information is converted into an image by a workstation computer. Malignant tissue absorbs more of the infrared light than normal tissue, and is displayed as a darker area on the scanner image.

The patient lies face down on an adjustable table. The breast that is to be examined is placed in a container filled with warm liquid, and stabilized between two immobilization plates. Unlike mammography, only soft compression of the breast is required and the patient is not exposed to ionizing radiation.

Breast Cancer in Canada

In 2006, an estimated 22,300 Canadians will be diagnosed with breast cancer and 5,300 will die from the disease[1].

Regulatory Approval

SoftScan is manufactured by ART Advanced Research Technologies Inc. (Saint-Laurent, QC). The technology is intended for use as an adjunct to x–ray mammography to provide additional information for diagnosis and treatment. SoftScan is not yet licensed by Health Canada.

Cost

The manufacturer estimates that when SoftScan is marketed, the price will range from US$600,000 to US$800,000.

Evidence of Efficacy

In a pilot study that used a prototype of the SoftScan device, scans were performed on 49 women who had either normal or abnormal mammograms.[2] In the 23 cases where a suspicious mass was detected by mammography, the SoftScan optical images diagnosed 11 cases as malignant and 12 as benign, which was identical to mammography results.

More studies are now underway. SoftScan is being investigated in a North American clinical trial, which includes sites in Alberta, Ontario, and Quebec. The trial is testing whether the combined use of SoftScan with x-ray mammography improves diagnostic accuracy compared with mammography alone. Study results will be used to seek regulatory approval in the US and Canada.[3,4] Another trial, at the Sunnybrook Health Sciences Centre in Toronto, will examine the role of SoftScan in monitoring breast cancer treatment.[5]

References

[1] Canadian Cancer Society, et al. Canadian cancer statistics 2006. Toronto: The Society; 2006. Available: http://www.ncic.cancer.ca/vgn/images/portal/cit_86751114/31/23/935505938cw_2006stats_en.pdf.pdf

[2] Intes X. Acad Radiol 2005;12(8):934-47.

[3] Adjunctive efficacy study of the SoftScan® Optical Breast Imaging System. In: ClinicalTrials.gov [database online]. Bethesda (MD): National Institutes of Health; 2006. NCT00267449. Available: http://clinicaltrials.gov/ct/gui/show/NCT00267449?order=1

[4] Miller A. Red Deer Advocate 2005. Available: http://www.art.ca/pdf/redDeerAdvocate_20051124.pdf

[5] ART receives Health Canada authorization to begin a breast cancer treatment monitoring pilot study for its SoftScan device [news release]. CCN Matthews 2006;(13 Jul). Available: http://tsedb.globeinvestor.com/servlet/WireFeedRedirect?cf=GlobeInvestor/tsx/config&date=20060713&archive=ccnm&slug=0337620001