The evaluation of a new device, Breastlight, for use as an adjunct to breast self examination and breast awareness by Mammocare, Ghana. The Breastlight Frank Ghartey and David J Watmough Developed in Scotland from Research carried out at Aberdeen and Edinburgh Universities. www.breastlight.com Presented at the Second Annual Africa Breast Cancer Conference, Cairo, Egypt. March 2009

The principal health concern of women is breast cancer. Why?        Because it is the commonest cause of death in women under 50.        In the UK there are 41,000 new cases per year and the trend is upwards.        There are 13,000 deaths per year from breast cancer.        5 year survival is 73%. This means 1 in 4 women die within 5 years of diagnosis.        The appropriate management of patients with early disease reduces mortality.

Why develop Breastlight ?  Earlier detection should also reduce the number of mastectomies in favour of breast conserving surgery.  Encourage women to examine their breasts so the disease presents at an early stage for diagnosis and treatment ?  PWB Health has developed a simple light-based product, the Breastlight which used together with breast self examination is designed to indicate the need for women to consult a GP for advice and possible referral.  It is small, safe, easy to use and is purposely chosen to be non-diagnostic. It involves no ionising radiation or breast compression.

Image of the device. Small, hand held device, battery operated Using light of wavelength 618 nm.

How does it work ? There is excess absorption of light passing through tumour associated blood vessels [i.e. Because of angiogenesis associated with expanding cancers ] which causes variations in brightness on the superior aspect of the breast.

HOW THE EXAMINATION IS CARRIED OUT. Breastlight is placed against the inferior surface of the breast in a fully darkened room. 3 high power Light Emitting Diodes are used. The camera is a Nikon D 70.

Typical images using Breastlight 1. Mass of 1.5 cm size in a 61 year old lady causes the shadow at 1 o'clock.

Typical images using Breastlight 2. Shadow from a 2 cm mass close to the nipple in the right breast. Note unwanted over illumination below nipple.

Typical images using Breastlight 3. Normal left breast for comparison. The dark area is the nipple. Superficial vessels are delineated.

Typical images using Breastlight 4. Some impalpable lesions produce shadows like this one at 12 o'clock.

Typical images using Breastlight 5. Breast mass of 1.5 cm size producing an extensive diffuse shadow in a 61 year old lady.

Mammocare, Ghana. Mammocare is a charity based in Accra, Ghana which teaches breast awareness and carries out clinical examinations on well women. Women found with symptoms are referred for X-Ray mammography [ the gold standard ] and then for a surgical opinion and treatment. Mammocare is ideally placed to evaluate the Breastlight as an adjunct to self examination. Women found to have clinical symptoms of breast disease have been examined using the device. The examination is carried out in a fully darkened room.

Results obtained using Breastlight. From July 2007 to December 2008 a total of 6085 women were clinically examined. Of these 475 were found to have breast symptoms or suspected symptoms. Among this group 49 have had breast cancer confirmed. The number with benign disease was 379. 47 [ 96%] of 49 cancers were positive using Breastlight. In all 47 cases the women themselves confirmed that they could see the shadow caused by presence of the tumour. Among 60 cases of benign disease 20 [ 33%] showed no shadow or other indication of abnormality.

Further studies. There were a few cases of shadows where no lump could be palpated and these cases are presently being followed up. Ideally it would be useful to examine a large number of women without symptoms using Breastlight rather than a selected group pre-examined clinically. Antiangiogenic drugs offer a new means of treatment of advanced cancers which targets the tumour blood supply and we plan a serial study recording images to demonstrate that the area of the shadow measured while using Breastlight decreases with time when the treatment is effective. The clinical version of Breastlight which incorporates light and Doppler ultrasound will also be evaluated as a therapy monitor.

References 1. Watmough D J [1982] A light torch for the transillumination of the female breast. British J. Radiology 55: 142. Watmough D.J. [1982]. Diaphanography; Mechanism responsible for the images. Acta. Radiologica Oncol. 21, 11-15. 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. Watmough D.J. Bhargava S. Memon A. Roy S. and Sharma P., [1997] Does breast cancer screening depend on a wobbly hypothesis ? J Public Health Medicine 19, No. 4, 375 – 379.

References 2. Watmough D J, Moran C and Watmough J A ‘ Son et Lumiere: a new combined optical and Doppler ultrasound approach to the detection of breast cancer’. J Biomed Eng 1988 10, 119 - 123. Wells P N T Halliwell M, Skidmore R Webb A J and Woodcock J P 1977 Tumour detection by ultrasonic Doppler blood flow signals Ultrasonics September 231 - 232

Next Steps. Evaluate prototype clinical version of Breastlight.

Isometric display of blood flow around the cancer. Tumour blood flow has characteristic features which require further study. Velocity, time and amplitude.

Sensitivity Study in Edinburgh 1986. Sensitivity was 0.94 (70/74)‏ age >50 years all cancers > 2cm (24/24) were correctly reported and 7 out of 8 for those < 2cm. age < 50 years 14/14 carcinoma > 2cm were correctly reported and 8/10 for tumours <2cm.

Combined Optical Doppler breast scanner 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 Radiology 68, 1344 - 1348. Optical and Doppler probes were seperate but data was processed by one computer. Light only sensitivity and specificity were 73% and 82%. Patients with locally advanced breast cancer showed dramatic changes to the images in concordance with response to chemotherapy.

Support from key experts. Professor Michael Baum writes

Further Support. Professor Karol Sikora.

THANKS FOR LISTENING