Breastlight™ 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%
|
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)
