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Clinical Trial Results

Published trials on Breastlight (Edinburgh & Aberdeen), using an earlier device, demonstrate that light-based technology can deliver high sensitivity levels (82%) in lesions over 1.5cm and useful levels (29%) in non palpable lesions.

Summary of consolidated results

Malignant tumours
Detected by device
Confirmed by biopsy
Detection rate %
Total
139
169
82%
> 2cm
95
106
90%
< 2 cm
23
31
74%
Non palpable
4
14
29%
Not measured
17
18
94%

Background 

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 tumours
  • 55 patients had cysts or other benign disease.

Detection rates with the device were:

Diagnosis
No diagnosed
Detected by device
%
Confirmed tumours
74
70
94.6%
Benign 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
No of patients
Detected by device
%
>2cm
38
38
100%
< 2 cm
15
18
83.3%

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
No of patients
Detected by device
%
>2cm
68
57
83.8%
<2cm
13
8
61.5%
Non palpable
14
4
28.6%

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

Method
Detected by device
%
Optical device
68/83
81.9%
Mammogram
69/83
83.1%

 

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