Case Study

Initial studies on the breast illumination method using earlier versions of the product were carried out in the 1990s. Clinical results for the technique were very encouraging in terms of distinguishing carcinomas from benign breast lesions. However the sensitivity was lower than that achieved with mammography and therefore the technique was not recommended as an alternative to established clinical screening methods.

Recent advances in LED Technology have enabled PWB Health to develop the Breastlight, an affordable, compact device for use by women in the home.

Breastlight screening device is designed to be a valuable aid to a women’s personal breast awarenessIn particular it can be of great assistance to women for whom palpation is not an effective way to identify wary masses for example those with fibrous breast tissue.

 

Earlier studies have shown that breast cancer can be demonstrated by transmission of light through the tissues (1,2). Optical images of cancer arise principally because of the associated angiogenesis.

Initial studies on the breast illumination method using earlier versions of the Breastlight device were carried out in the Edinburgh Royal Infirmary and the University of Aberdeen.

Results:

The Edinburgh study (3) included a total of 129 patients with palpable lesions. Of these:

  • 74 patients had confirmed tumors
  • 55 patients had cysts or other benign disease.
Diagnosis​ No Diagnosed By Device Percentage
Confirmed Tumours
74
70
94.6%
Begin Disease
55
50
90.9%

False positive declarations were made on patients with blood filled cysts and abscesses.
In 56 of the patients the size of the lesions was estimated by the use of callipers. Detection rates with the device were:

Lesion Size​ Patients​ By Device Percentage
>2cm
38
38
100%
<2cm
15
18
93.3%

The Aberdeen (4) study involved 178 patients. Of these:

  • 69 had normal mammograms
  • 109 had abnormalities detected by mammography

Of the latter, 95 had confirmed breast cancer:

  • The device detected 69 of the tumours (72%)
  • Of those not detected, 8 were ductal carcinomas in situ; average size of cancers missed was 1.1cm

Detection rates by size of tumour amongst the 95 patients were:

Tumour Size​ Patients​ By Device Percentage
>2cm
38
57
83.3%
<2cm
13
8
61.5%
Non Palpable
134
4
28.6%

Of the 83 patients where no cancer was present, device detection rates were compared with mammography:

Method By Device Percentage
Optical Device
68/83
81.9%
Mammogram
69/83
83.1%

Sources

  • Cutler 1929
  • Watmough 1982
  • Bundred et al 1985 – download a copy of the Edinburgh trial (pdf:document)
  • Brittendon et al 1995 – download a copy of the Aberdeen trial (pdf:document)

Download a summary of all the clinical and user trial results (pdf:document)

Download a copy of  ‘Breastlight – a novel mode of looking at breast cancer with a significant potential and an example of alternative approaches to research’ by Jayant S Vaidya and Mangesh Torat (document)

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Large Scale User Evaluation

In July 2008 PWB Health commissioned an independent market research company to carry out a large scale study on Breastlight usage.
The objectives of the study were to assess how Breastlight was used, how it affected women’s attitude to breast awareness and breast screening and to give an indication of the frequency of referrals.
breastlight-normal-breast
What to look for

When you are looking at your breasts with Breastlight you may also see other dark areas. These could look like very dark spots or a shadowy area.

breastlight-normal-breast
What You Will See

You will see veins & other blood vessels as dark shadow lines in your breast. Around nipple you may see circle of small dots – these are part of your mammary glands.

breastlight-normal-breast-screening
Normal Breast

This picture is the example of normal healthy breast.

breastlight-detect-lump
Lump Found

This picture shows Lumps found on breast.

breastlight-reviews
Sarah Johnson

People Say

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John Doe
Designer