Development of BREAST-i

Update : read a new research paper - BREAST-i is an effective and reliable adjunct screening tool for detecting early tumour related angiogenesis of breast cancers in low resource sub-Saharan countries (pdf) - to be published shortly in International Journal of Breast Cancer.

Enquiries from distributors are welcome. Contact us to register interest.

HIC needs your feedback on BREAST-i, which should lead further improvements in female health care. See a list of granted patents, design copyright, trade mark and domain names. HIC are working on a clinical version of BREAST-i to monitor treatment of advanced breast cancer prior to surgery.

Breast-i home use device for breast examination
BREAST-i home use device for breast examination.

Testing of BREAST-i in Africa

The first BREAST-i was sent to a clinic in Africa, where to date 1,460 women have been examined. The sensitivity for cancers is estimated at 94.4% and after an initial charge of the batteries a series of 70 examinations could be carried out before the light intensity began to drop off. The precursors to BREAST-i, BreastChecker and Breastlight , have been used in over 8000 examinations at the same clinic. In some developing countries other techniques - like the gold standard for screening, X-ray mammography - are not widely available.

In parts of Africa, India and China our belief is that BREAST-i may have an important role in developing countries.

X-ray mammography can pick up tiny cancers sometimes indicated only by flecks of calcification in breast tissues. The irony is that for some time now the best treatment for minute cancers is not known, since some may grow to become life threatening, others may remain dormant and some might disappear. Any cancer detected by BREAST-i is highly likely to be life threatening since it is detected by associated angiogenesis implying that it is already in the exponentially growing phase. It must be realised that X-rays and light are monitoring different features of the breast, tissue density and neovascularisation, respectively.

Performance of BREAST-i

The BREAST-i is designed to be used by women with breasts of various sizes and pigmentation, using state-of-the-art light emitting diodes. The device is able to comfortably cope with Ghanaian women, many of whom have large breasts and dark skins. A comparative study of relative light intensities carried out independently is shown here:

Comparison of relative luminosity between devices
Comparison of relative luminosity between BREAST-i, BreastChecker and Breastlight.

Read the article BREAST-i Device To Detect Breast Cancer at Spy Ghana, Ghana's leading general news and information destination online.

History of research & development leading to new BREAST-i

On July 11th 2007 HIC signed a license agreement with a newly created company PWB Health Ltd based in the West of Scotland to produce a commercial version of the original BreastChecker and to sell it worldwide. HIC transferred prototypes, clinical data, know-how and IP to PWB Health Ltd.

The staff of PWB Health Ltd had good electronic and good design experience and produced the Breastlight, shown together with the BREAST-i here:

Breastlight and Breast-i devices
Breastlight produced by PWB Health Ltd and Wideblue Ltd under a license agreement with HIC. Below it for comparison the new BREAST-i. The LEDs in BREAST-i are more efficient and do not require a large, complicated heat-absorbing mass. The battery box cover can be removed with the new design to replace a battery pack.

Breastlight is aesthetically pleasing but in our opinion the the narrow swan neck design led to teething problems not initially foreseen. To image breast tissues high intensity light from three red light emitting diodes was required and these sources also generated heat which had to be conducted away to prevent burn out of the LEDs. An aluminium heat sink was bonded to the LEDs to keep the temperature low. It had to be made in a complicated shape to pass through the narrow swan neck and to have enough capacity it occupies a large portion of the handle not taken up by batteries and electronics. The complex shape of the heat absorber led to a high cost of tooling needed to make it.

The upshot was that the rechargeable batteries could not be replaced by most users. If the batteries failed the device had to be returned to the manufacturer. A second problem with the original version was that the device measured the time since last use (e.g. 31 days), which resulted in a constant current drain. Battery voltages of devices in storage dropped so low that in some cases the recharging circuitry failed.

Notwithstanding these limitations, Breastlight was subjected to a successful clinical trial in a NHS Hospital. The sensitivity in terms of detecting cancer was 67%, a surprisingly high figure bearing in mind that the tests were carried out by nurses not initially familiar with this technique, and the relatively low cost of the device. Subsequently a paper published in the Asian Pacific Journal of Cancer claims sensitivity for cancer detection of 93% in a study conducted in Cairo, Egypt (pdf). The high figure may be due to late presentation of women thus harboring larger tumors. Tumors larger than 10mm are easier to detect using light.

European Patent & Design Copyright (including China) for BREAST-i

A European Patent application for 'improved BreastChecker' went to grant in May 2013 and covered the essential features of Breastlight but with priority from May 2005 before any agreements with PWB were signed. The main features of the patent are advanced sensor technology to suppress light unless the device is in contact with tissues which prevents the user looking directly at the high intensity LEDs, and also the device is programmed to remember light intensity at last use so that the user's breasts should look the same at every examination unless pathological changes have occurred in the interval.

We have not relied solely upon the patent for protection of IP but also taken out design registration in UK and China. We have also registered BREAST-i as a domain name and as a trademark.

Following the grant of the European patent, HIC were able to raise a modest amount of private equity and a balancing grant from Highlands & Islands Enterprise. We have used a specialist electronic company to develop the new BREAST-i with a view to improved performance and reduced cost.

The physical design of BREAST-i was carried out by a designer working for an internationally known company. The accessible battery compartment was a must. Pink has been incorporated as a design feature because of the connection to pink ribbon month when funds are raised for breast cancer charities. The performance of the LEDs incorporated in BREAST-i have improved giving more light while generating less heat so requiring a smaller uncomplicated heat absorber. We kept the geometry of the exit pupil of the device virtually unchanged and chose the same light wavelength, so that previous clinical testing is applicable.

Historic development of BREAST-i

BreastChecker, Breastlight and Breast-i devices
The BreastCheckers, black and white versions (left), were forerunners of Breastlight. During 2014 we developed BREAST-i (extreme right) to overcome the limitations of Breastlight (second from right) and provide an enhanced performance.

Two BreastCheckers, one Breastlight and one BREAST-i are shown here (left to right).

The two BreastCheckers were developed prior to the licensing agreements with Wideblue Ltd then PWB Health Ltd. In the last year the LED technology has improved, allowing more light if required for less unwanted heat. Thus BREAST-i allows larger, denser breasts to be examined.

HIC has always been careful not to over-hype the devices and to recognise that their use encourages breast awareness. We also point out that BREAST-i is not alternative to breast cancer screening by X-Ray mammography, however in the intervals between screenings keeping an eye out for interval cancers is recommended. Younger women with dense or lumpy breasts are not called for breast cancer screening and BREAST-i may have a role here.

Intellectual Property Registration

Registered Patents

Description Jurisdiction & Registration Number
Portable non-diagnostic domestic apparatus for self-checking female breasts or testicular tissues to detect the occurrence of breast or testicular diseases United Kingdom Patent Office GB 2375672 B
Apparatus for in vivo monitoring of the effect of antiangiogenic drugs on cancers German Patent Office EP1253856
Apparatus for in vivo monitoring of the effect of antiangiogenic drugs on cancers United Kingdom Patent Office EP1253856
Apparatus for in vivo monitoring of the effect of antiangiogenic drugs on cancers French Patent Office EP1253856
Apparatus for examining a body of living tissues (improved BreastChecker) European Patent Office EPO5741888.1 (ex PCT/GB2005/001777)
Apparatus for examining a body of living tissues (improved BreastChecker) United Kingdom Patent Office (IPO) P3032EPGB
Apparatus for examining a body of living tissues (improved BreastChecker) French Patent Office P3032EPFR
Apparatus for examining a body of living tissues (improved BreastChecker) German Patent Office (IPO) P3032EPDE

Registered Designs

Description Jurisdiction & Registration Number
Breast Checker Community Design (OHIM) 000723036-0001
BREAST-i Community Design (OHIM) Applic. 4034270
BREAST-i Community Design China - details awaited

Other Intellectual Property

File patent listing BREAST-i UK IPO Trademark
260314A UK00003036859

Subsequent events

A "credit" to the designers of Breastlight was the making of an unauthorised Chinese copy, complete with copied packaging and copied breast images, which we discovered and purchased online. Unfortunately the batteries were removed and a vibrator installed to replace them. The device is mains operated and the firm doing the copying ought to know that vibrating a malignant tumour is most dangerous as it could cause metastases (secondary tumours).

Chinese copy of Breastlight called 'Breastangel'
On the left is the HIC version of the domestic BreastChecker and in the centre is the licenced PWB version, Breastlight. On the right is the unauthorised copy of Breastlight made in China and branded Breastangel.
Interior of Breastangel showing vibrator
Interior of Breastangel showing vibrator replacing battery.

Future work on clinical BreastChecker

The clinical version of the BreastChecker is shown in the figures above and depends on the combined use of light and ultrasound. Software to analyse the Doppler ultrasound signals has been developed and is obtained in real time on a laptop (Apple or PC Computer).

Clinical BreastChecker interface and graphs
The clinical BreastChecker interfaces to a computer and analyses the blood flow to the tumour or suspected tumour. Neovascularisation would indicate the presence of a cancer and in course of effective treatment the amplitude of signals would reduce or disappear.
BreastChecker integration with PC or Mac with amplifier
Here the mini amplifier allows the audio blood flow signal from the tumour to be heard as well as recorded and replayed. Software for PC and Apple computers has been already developed.

Examples of images obtained using light

Most images were obtained in Ghana.

BreastChecker image
Small shadow adjacent to the nipple, possibly with enlarged blood vessels.
BreastChecker image
Marked abnormality at 12 o'clock extending to the nipple.
BreastChecker image
Circumscribed abnormality with suggestion of angiogenesis situated at 12 o'clock.
BreastChecker image
Focal abnormality, shadow at 11 o'clock.
BreastChecker image
Diffuse abnormality from 1 o'clock to 6 o'clock.
BreastChecker image
Normal image for comparison showing nipple areola and superficial blood vessels.

References

  1. Frank Ghartey, David Watmough, Samuel Debrah, Martin Morna, Akwasi Anyanful [2018] International Journal of Breast Cancer - BREAST-i is an effective and reliable adjunct screening tool for detecting early tumour related angiogenesis of breast cancers in low resource sub-Saharan countries (pdf)
  2. BREAST-i screening report from March to October 2017 from Mammocare Ghana (pdf)
  3. Labib N A, Ghobashi M M, Moneer M M et al [2013] Asian Pacific J. of Cancer Prevention, vol 14, 4647-4650 - Evaluation of BreastLight as a Tool for Early Detection of Breast Lesions among Females Attending National Cancer Institute, Cairo University (pdf)
  4. K J Jørgensen, P C Gøtzsche, M Kalager, P Zahl [2017] Ann Intern Med., DOI: 10.7326/P16-9029 - Breast Cancer: Tumor Size and Overdiagnosis (pdf)
  5. Ghartey F and Watmough D. J. [2009] South and East Mediterranean College of Oncology, Second Annual Breast Cancer Conference 17- 19 March Evaluation of a new device Breastlight, for use as an adjunct to Breast Self Examination and Breast Awareness by Mammocare, Ghana.
  6. Brittenden J. Watmough D.J. Heys S.D. and Eremin O. [1995] Preliminary clinical evaluation of a combined optical Doppler ultrasound instrument for the detection of breast cancer. Brit. J. Radiol. 68, 1344 - 1348.
  7. Bundred N., Levack P., Watmough D.J., and Watmough J.A. [1986]. Preliminary results using computerised tele-Diaphanography for the investigation of breast disease. British J. Hospital Med. 37, 70-71.
  8. Watmough D.J., Quan K.M., Aspden R.M., and Mallard J.R. [1992] Phantom study of tissue compression: possible implications for the use of X- ray mammography as a method of imaging breast carcinoma. Europ. J. Surg. Oncol. 18, 538 - 544.
  9. Watmough D.J., and Quan K.M. (1992). X-Ray Mammography and breast compression. The Lancet, 340 (July 11, 1992), 122.
  10. Watmough D.J. [1982]. Diaphanography; Mechanism responsible for the images. Acta. Radiologica Oncol. 21, 11-15.
  11. Watmough D.J. [1983] Transillumination of breast tissues: Factors governing optical imaging of lesions. Radiology 147: 89-92, April 1983.
  12. Watmough D.J. [1989]. Son et Lumiere; a combined Optical Doppler ultrasound approach to detection of breast cancer. Rad. Magazine Jan. 1989.
  13. Watmough D.J., Quan K.M., and R.M. Aspden. [ 1993]. Breast compression; a preliminary study. J. Biomed. Eng. 15, No.2 121 - 126.
  14. Watmough D.J. [1983]. Diaphanography. Chapter 6 in the book Medical Imaging [Editor Daphne Jackson ] Surrey University Press, 217-225.
  15. Watmough D.J., [1981]. Breast transillumination using the Sinus Diaphanograph. Brit. Med. J. 284. 111-112.
  16. Hussey J.K., MacDonald A.F., Nichols D.M., and Watmough D.J. [1981]. Diaphanography; a comparison with mammography and thermography. Brit. J. Radiol. 54, 163 [abstract]
  17. Bhargava S, Watmough DJ, Syed F, Memnon A and EL-Gharbawy IF [1996] High detection rates do not necessarily lead to lower mortality. BMJ, 312, 24th February, 509.
  18. Watmough D.J. and Sharma P.N. [1995] Two sides of the same coin? Invited commentary. Medical Principles and Practice. [92-93 ], 3, 232 - 234.
  19. Watmough D.J. [1993] Interval Breast Cancers. American J Roentgenology July 1993, 161, 3.