VALIDATION OF BREAST TRANSILLUMINATION TECHNIQUE IN

EVALUATION OF BREAST LESIONS AMONG UGANDAN WOMEN

BY

Dr. ELOBU EMMANUEL ALEX

MD (Dar)

A RESEARCH PROPOSAL FOR A DISSERTATION TO BE SUBMITTED TO THE

SCHOOL OF GRADUATE STUDIES IN PARTIAL FULFILLMENT OF THE

REQUIREMENTS FOR THE AWARD OF THE DEGREE OF MASTER

OFMEDICINE IN SURGERY OF MAKERERE UNIVERSITY

October 2010

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Contents
INTRODUCTION ..................................................................................................................... 3
LITERATURE REVIEW .......................................................................................................... 4
PROBLEM STATEMENT ........................................................................................................ 8
SIGNIFICANCE ........................................................................................................................ 9
OBJECTIVES ............................................................................................................................ 9
RESEARCH QUESTIONS ..................................................................................................... 10
HYPOTHESIS ......................................................................................................................... 10
METHODOLOGY .................................................................................................................. 11
REFERENCES ........................................................................................................................ 14

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INTRODUCTION
Breast cancer is a problem of global proportions. About one third of all cancers diagnosed

worldwide are of the breast. Incidence and mortality vary widely internationally [1] In

Uganda breast cancer is the third most commonly diagnosed cancer after Kaposi sarcoma and

cancer of the uterine cervix[2]. The incidence of breast cancer has tripled in the past three

decades and stands at 39.2 per 100,000[3]. The documented peak age for breast cancer in

Uganda is 30-39 years. A majority (77%) of the patients present with stage III and IV disease

with five year survival of 39% [4].

Breast cancer is thus a disease of great public health interest in Uganda. More efforts and

resources therefore need to be allocated to all aspects of its management including prevention

and treatment. The current knowledge of the disease has not revealed an effective primary

preventive measure. Secondary prevention therefore offers the next feasible strategy in

combating this disease

Currently the best chance of reducing breast cancer morbidity and mortality for breast cancer

is early detection[5]. The best prognosis is carried by small breast tumours(less than 15mm

diameter) without nodal or distant metastases[6]. At this early stage, curative treatment is

feasible. But at this early stage, the disease is most times asymptomatic and therefore

diagnosis is delayed. This goes to emphasize the role of breast cancer screening programs in

early detection of disease. Screening is effective in reducing mortality due to breast cancer.

The use of mammography has been clearly shown by powerful studies to reduce breast

cancer mortality by up to 25-30 % in females aged above 50 years [5-7].

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LITERATURE REVIEW
Mammography is currently the gold standard in breast cancer screening. It has a documented

sensitivity of 63-95 % sensitivity (>95% for palpable lesions) and specificity of 14-90%[3].

In developed countries routine annual mammography is recommended for all females of 50

years and above[8]. It however has a number of disadvantages including low sensitivity

(50%) for impalpable lesions[3]. It involves the use of ionising radiation, the effects of which

may accumulate with repeated examinations. Indeed some cases of breast cancer have been

documented that are attributable to irradiation from mammographic screening. However, the

authors of that same study did a risk-benefit analysis that was clearly in favour of

mammographic screening even if started at 40 years. Another systematic review of

mammography among women 40-49 years of age showed that there exists a risk albeit

minimal of developing breast cancer attributable to mammography but benfits of

mammography clearly outweigh that risk[9]. It is also relatively observer dependent in its

accuracy. During mammography, the breast is compressed with pressures of up to 200N

(approximately 20kg) which several women have reported as uncomfortable , however many

women report it as bearable and would not cause the to default from screening.

Its use is best for less dense breast tissue thus limiting its use in younger female(less than 40

years) its use is also further limited by in the African females who tend to have denser breast

tissue than their white counterparts even at older ages. In Uganda, there are only five

mammography machines which are inequitably distributed to the urban areas. Also, three of

these machines are privately owned and attract a fee of about $25, a fee that is way beyond

affordable for the average Ugandan female[3].

Other screening tests that could be considered are breast self examination, clinical breast

examination, breast ultrasonography and breast transillumination.

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Breast self examination although seemingly easy is not without its technical difficulties. A

study of Ugandan university women revealed that although many females had heard of breast

self examination (81.5%) only 30% had ever done it and only 1% could demonstrate a correct

examination[10]. Also research into BSE as a screening modality has not been shown to

improve survival in breast cancer. A large randomised clinical trial involving over 200,000

Chinese women demonstrated this. In this trial the incidence and mortality of breast cancer

was similar among women who regularly performed BSE and those who did not, clearly

showing no benefit from BSE as a screening modality [11]. A meta analysis of 12 studies on

BSE also failed to clearly show a benefit of BSE in reducing breast cancer mortality[12]. The

Breast Cancer Committee of the Society of Obstetricians and Gynaecologists of Canada

modified their recommendations and discouraged the use and teaching of breast self

examination as it has failed to result in reduced mortality[13]. The American Cancer Society

no longer advocates for BSE in breast cancer screening and states that it is acceptable for

women to do BSE irregularly or chose not to at all[8]. It suffices to say that BSE is currently

very unpopular among professionals in breast cancer management.

Clinical breast examination has been evaluated as a screening test and found to be grossly

inadequate on its own. The benefit of CBE alone in breast cancer screening has not been

demonstrated even in the United States of America where up to 70% of women over 40 years

undergo regular CBE[14]. The documented sensitivity of CBE is 21%-54% [7, 14-15]. The

use of CBE simultaneously with mammography has been shown to increase the overall

sensitivity. One study demonstrated an increase in sensitivity from 78% with mammography

to 82%[16] and it is for this reason that the American Cancer society recommends that CBE

be performed together with mammography in breast cancer screening[17]. In one of the

validation studies on CBE a sensitivity of 46% was revealed, however the very authors of

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this study noted that this sensitivity was way too low to make CBE an effective screening

tool[15].

Breast ultrasonography has not been widely studied as possible screening modality, probably

in part due to the greater success seen with mammography. It however has a sensitivity of 68-

97% and specificity of 74-94%[3]. Ultrasound examination offers great potential in

examination of breast in the younger population with high breast tissue density that precludes

meaningful mammographic examination. This would be especially advantageous to Uganda

where majority of cancers are seen at an earlier age. Uganda has over sixty ultrasonography

machines. This could potentially narrow to some extent, the huge gap in breast cancer

screening left by the few mammographic machines.

Breast transillumination technology is not commonly known even in the medical circles. The

technology has however been around for some decades now. It has undergone tremendous

evolution over the years. The first attempt at transillumination was by Cutler M in 1929 when

he shone a light through the breast that could delineate abnormal tissues as dark areas[18].

Although crude in the beginning, the technology has been modified to the level of a handheld

user operated device known as the breastlight. This device shines an infrared light through

the breast that can be perceived on the opposite side by the naked eye. Normal breast tissue

transmits the infra red wavelength of light without distortion. Haemoglobin in the

erythrocytes within the blood vessels of the breast however absorbs the light and appears as

dark areas. Cancerous lesions in the breast like many other tissues tend to undergo

angiogenesis. Without angiogenesis, no tumour would be able to grow beyond 2 mm in size.

Therefore the tumour with its numerous blood vessels would appear as a focal area of

darkness. Validity studies done in the United Kingdom have so far shown sensitivity 67-95%

with up to 100% for lesions greater than two centimetres in one study. Specificity

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These studies are still few. Also, these studies were mostly among white populations whose

breast density has been shown to differ greatly from their lack age mates. On study done in

Ghana as part of their Breast cancer clinic screening and follow up as showed that the

breastlight demonstrated abnormal lesions in 16 patients that were eventually proved to have

breast cancer. The breastlight device costs about $85 Breast transillumination technology in

the present form of a highly portable breastlight is easy to use, relatively cheap and yet has

sensitivity comparable to the gold standard mammography.

For a screening test to come close to ideal, it should be:

non-invasive

safe to both the screened individual and operator

relatively easy to use

cheap

For a disease to warrant a screening program, several criteria must be met if the screening

will actually be effective both practically and in terms of cost. These include;

Prevalence greater than 1%

Ability to be detected at early stages

Curability in the early stages

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PROBLEM STATEMENT
Breast cancer is the third commonest cancer among females in Uganda[2] with a rising

incidence, currently at 39.2% per 100,000per year[3]. It presents in a younger age group 30-

39 years as compared to the 50-59 in the developed world. In Uganda most (77%) patients

present in stage III and IV which are incurable[4]. Early detection by effective screening

programs provides the best hope for improving the outcome of breast cancer management in

terms of morbidity and survival[5]. Uganda, however does not have a Breast Cancer

screening program and nor will there be one in the foreseeable future. Mammography is the

current gold standard for screening for breast cancer. In Uganda however, few mammography

machines exist, they are inequitably distributed and too expensive for most women [2-3].

Uganda has approximately 6,400,000 females needing breast cancer screening, however

about half of these would be excluded from mammographic examination because of being

younger than 30 years[3]. With the above background poor countries are forced to look for

alternative modes of screening that are cheap and yet reliable. Much hope was initially placed

in breast self examination because it would empower every woman to screen herself and yet

still be cheap and easy to carry out[2]. Research has however proved that BSE is unable to

improve breast cancer survival. Breast transillumination thus offers us the next best solution.

The Breastlight is a portable torch like device that employs the transillumination technique. It

is relatively cheap, safe for operator and easy to use. It also has negligible maintenance costs.

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SIGNIFICANCE
Breast transillumination technique in its current form as the Breastlight has a documented

sensitivity of 67-95%. If similar sensitivity patterns can be demonstrated among Ugandan

women, then it would go a long way to narrow the huge gap in breast cancer screening in the

country. It is a portable and easy to use device. Indeed it was developed for use by individual

women. It is also cheap and has almost negligible maintenance costs. It doesn’t have the age

restriction associated with mammography and can be used at any age.

The device could be distributed among many health facilities all over the country thereby

affording many women a safe and reliable method of examining their breasts for any

abnormal lesions.

This device therefore has potential for being an affordable, easy to use sensitive device for

breast cancer screening in Uganda. It may also be used by individuals which would be a form

of enhanced breast self examination. This would empower the woman to take charge of her

own health and limit need for high level experts and expensive technology.

OBJECTIVES
To validate the use of breast transillumination technology in the evaluation of breast lesions

among Ugandan women

Specific objectives

1. To determine the difference in sensitivity, specificity and predictive values between

breast transillumination technique and mammography in the evaluation of breast

lesions among Uganda women

2. To determine the features on breast transillumination that may be indicative of benign

or malignant breast disease as confirmed by histopathological examination

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RESEARCH QUESTIONS
Is the validity of breast transillumination technique comparable to mammography in the

evaluation of breast disease among Ugandan women?

What are the features on breast transillumination that are indicative of benign or malignant

breast lesions as confirmed by histological examination?

HYPOTHESIS
Null hypothesis

There is no difference in sensitivity, specificity and predictive values between breast

transillumination technique and mammography among Ugandan women at Mulago national

Hospital

Alternate hypothesis

There is a difference in sensitivity, specificity and predictive values between breast

transillumination and mammography among Ugandan women at Mulago national Hospital

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METHODOLOGY
Study design

An analytical cross sectional study design shall be used.

It is the best suited study design to answer the research question

Study setting

Mulago Hospital is one of three national referral hospitals in the country. It is also the

teaching Hospital for the Makerere University College of Health sciences. It has a bed

capacity of about 1500. The breast clinic and Endocrine surgery Unit where the study shall be

conducted are run by the Green firm of the Department of Surgery. The Breast Clinic is run

once a week on Wednesdays in the Surgical Outpatient’s department. Many patients present

with lumps. The endocrine Surgical ward housed on ward 3C receives patients from the

Breast Clinic, other endocrine clinics, 3 BE Surgical emergency ward and occasional

transfers from other wards. In the past three years an average of 200 incident cases of breast

cancer were registered per year.

Study Participants

Target population-all Ugandan women at risk of developing breast cancer

Accessible population-all women attending the breast clinic or those admitted to the

endocrine surgical ward with breast disease.

Study participants-All women attending the breast clinic either for medical attention to breast

symptoms or screening. All women admitted to endocrine surgical ward with breast disease.

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Eligibility criteria

Inclusion criteria

All above women 30 years or greater attending the breast clinic or admitted to

endocrine surgery ward who have had mammography done.

All women above 30 years attending the clinic for breast cancer screening or any

other women interested in being screened for breast cancer.

Exclusion

women who decline to participate in the study

pregnant or lactating women

Sample size ---

Sampling Method

Consecutive sampling method shall be used until the required sample size has been achieved.

Procedure

Women who meet the inclusion criteria shall be invited to participate in the study. A

thorough explanation shall be provided of the actual research activity, the potential risks

involved and the benefits of the study. Informed consent shall then be obtained. The

investigator shall then proceed to do a clinical breast exam followed by an evaluation with

the breastlight. The breastlight examination shall be conducted in a dark room.

Confidentiality and patient decency shall be maintained at all times. The findings shall be

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recorded. The investigator shall then obtain a copy of the mammography report from the

participant. A biopsy shall then be done for lesions detected by one of or both mammography

and breastlight.

Data management

Raw data i.e. reports of clinical examination, breastlight evaluation, mammography and

pathological examination shall be kept in sealed coded envelopes. This data shall then be

entered in a statistical software package for analysis

Data analysis

The data shall be used to calculate sensitivity, specificity and predictive values comparing

breastlight to mammography and then histological examination. The examination findings on

breastlight examination shall be analysed against histopathological findings. A chi square test

shall be used to test for statistical significance. Statistical significance shall be set at 0.05

Ethical considerations

Ethical clearance shall be sought from the Hospital committees of both Mulago National

hospital and Makerere University College of Health Sciences

Limitations

The study shall be conducted in a hospital setting thus representing a selection bias as a large

number of symptomatic participants may end up being recruited. A validity study for a new

test would have best been done alongside an established screening program.

Dissemination of results

The results of this study shall be disseminated through various libraries, workshops,

conferences and journal publication.

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