For Appointments (302) 678-DOCS(3627)
If you are in need emergency medical care,
Please dial 911 immediately!!
General Surgery

Diagnosis and the Triple Test

Diagnosis and the Triple Test

General practitioner consultations for breast symptoms have been increasing annually in a great proportion. Although majority of women with breast problems will not have breast cancer, they often become anxious and worry about their breast changes as cancer. There are several causes for breast changes, most of which are not dangerous or harmful. The reported prevalence of breast cancer in women complaining with breast symptoms is about 2–10%. However, all new breast symptoms and clinical abnormalities must appropriately be investigated to exclude cancer.

‘Triple test’ – the combination of clinical examination, breast imaging, and nonsurgical biopsy maximizes the chance of accurate diagnosis. Interpretation of the triple test result is critical. Therefore, further assessment is recommended if there is any inconsistency, or all three parts of the triple test results are not definitely benign.

What investigations will a physician recommend?
As per recommendations, physicians use the “triple test” approach to determine the cause of breast changes. However, it should be noted that most women with breast changes would not need this triple test.

The Triple Test Approach

The triple test approach consists of three diagnostic components:

  • Medical history and clinical breast examination
  • Imaging: Mammography and/or Ultrasound (+/-MRI)
  • Non-excisional biopsy: Fine Needle Aspiration (FNA) cytology and/or core biopsy, during which a sample of cells or tissue is extracted from the lump.

The sensitivity of the ‘triple test’ is greater than each individual diagnostic component. The result is positive if any component is indeterminate, suspicious, or malignant.

The clinician should correlate the pathological results with the clinical and imaging findings of the patient. Most women show no signs of cancer on these tests, but those who show a positive result for one or more of the tests will be advised to undergo further investigations. Usually, it is recommended to take complete responsibility of the triple test and its entire investigative pathway by a single physician. It helps in drawing a better correlation from the results and symptoms.

Patient History and Clinical Examination
Patient history and clinical examination furnish important information that helps in further investigation.

Patient history
Relevant history includes details regarding:

  • Current medication or recent changes, especially hormones such as the pill/HRT
  • Hormonal status/ menstrual history
  • Previous breast problems, particularly breast investigations and biopsy results
  • Risk factors, particularly strong family history of breast or ovarian cancer
  • Previous/recent imaging, date and results, screening or diagnostic
  • Also, the history of presenting symptoms
  • Site — constant or changing
  • Duration — when and how first noticed
  • Any changes since first noticed
  • Relationship to menstrual cycles or exogenous hormones
  • Associated symptoms

Clinical Breast Examination

Your physician examines your breast for any visible changes, after having you relax in a seating position with all the upper half body clothing removed. Afterwards, you will be asked to lie down, so that the physician can examine your breasts and nipples as well as the armpits.

The physical examination should establish the nature and site of any abnormality, particularly the presence of a discrete lump or textural change noticed either on visual inspection or on palpation of the breast. The findings of the clinical examination should be correlated with the symptoms the patient, especially any abnormalities reported through imaging.

Diagnostic Imaging

There is a distinction between diagnostic breast imaging and breast screening. Breast screening is an assessment for women who have no breast symptoms and its main objective is to detect breast cancer at an early stage, usually using mammography alone. Whereas, diagnostic imaging is advised for women with breast symptoms and it includes mammography and ultrasound to determine the cause of their symptoms and to exclude breast cancer as a cause.

The sensitivity of both mammography and ultrasound increases with increasing age. But, results with ultrasound are significant only in women under the age of 50 years. Therefore, both mammography and ultrasound can be considered complementary for evaluating breast abnormalities. Mammography and ultrasound together will correctly identify about 95% of breast cancers in symptomatic women. Therefore, besides diagnostic imaging, clinical opinion is also equally important to decide if further examination such as biopsy is required.

Mammography

Mammography is a low dose X-ray of your breasts. People may be concerned about the amount of radiation due to the use of X-rays, but mammograms require a very low dose of radiation.

A female mammographer, an expert in taking breast X-rays, will ask you to undress to the waist and stand in front of the mammography machine. You should inform the mammographer if you are pregnant or you may be pregnant. You will be standing with your breast on the X-ray machine before it is gently but firmly compressed by a Perspex plate so that all the breast tissue can be seen. Two or more images of each breast will be taken to view it from different angles.
Some may find mammography quite uncomfortable or even painful, but the discomfort or pain lasts only for a few seconds and is not harmful. The breast is compressed in order to keep it still and get a clear picture. Mammography itself may take only a few minutes to perform, but you may have to wait for a short time while the technician checks if any additional images and different views are required. Further mammograms at different angles with different magnification may be required to examine specific areas of the breast.

Women with breast implants can still have mammograms, but it is important to inform the mammographer in advance. It will be helpful for making proper arrangements to view as much breast tissue as possible on the mammogram. Mammography should be recommended for women of all age groups if the clinical or ultrasound findings are suspicious or malignant.

Breast Ultrasound

Ultrasound scan uses high-frequency sound waves to produce an image of the breast tissue. This is similar to the imaging technique used to scan babies in a pregnant women’s womb. Ultrasound scan is painless and the length of time is usually a few minutes, but is variable. You will be asked to undress to the waist and lie on a couch with your arm above your head. Some lubricating gel will be spread over your breast to help provide a clear view. The sonographer will use a hand-held scanning probe called a transducer, which will be moved over the breast to look at the underlying breast tissue.

Irrespective of the age of women, an ultrasound scan will usually be done together with the mammogram. Both provide different information so often they are used in conjunction.

Ultrasound:

  • It is the breast imaging test for young women (
  • Useful in the evaluation of a specific lump or lesion in women of any age
  • Very accurate when clinically guided or directed to an identified abnormality
  • Highly operator dependent
  • Preferred over mammography for image guided intervention such as biopsy and hook wire localization, if possible, because it:
    • Avoids radiation
    • Allows ‘real time’ visualization of needle or wire tip in relation to lesion
    • Avoids compression of the breast and is more comfortable for the patient
    • Is takes less time than mammography

Breast Magnetic Resonance Imaging (Breast MRI)

Breast MRI is an imaging technique, which uses a magnetic field to produce images of the breast tissue. It does not involve any radiation exposure as with mammogram. For breast MRI, you will lie on a bed facing down and the images will be taken having you passed through a tunnel. During MRI, your breasts hang into special devices called breast coils to improve the quality of the images. Like mammogram, breasts are not compressed during an MRI. It takes about 30–45 minutes for complete imaging, during which hundreds of images are taken in a quick manner and they get stored in a computer for further analysis. An injection that highlights the blood flow in breasts is given into a vein in your arm, and the images are taken before and after the injection. This injection helps the radiologist decide if a change in the breast is cancerous or not.

Breast MRI is not suggested as a diagnostic test for women at average risk. Women with symptoms and/or lesions seen through imaging should be assessed with the traditional triple test- clinical examination, imaging (mammography and/or ultrasound), and percutaneous biopsy. Except in very specific clinical conditions, an MRI is useful in testing women with breast symptoms.

There is an increasing level of awareness of breast MRI among women with breast symptoms consulting general practitioners and specialists. However, it should be noticed that an MRI should be used very selectively while investigating and diagnosing breast symptoms. Medicare reimburses the cost of breast MRI only to those who satisfy a strict eligibility criteria i.e. having potentially high risk of breast cancer by virtue of a strong family history. Medicare rebate for Breast MRI is not available to women with breast symptoms.

Practice Tips

Under age 35

  • Ultrasound is recommended as the first imaging modality.
  • Mammography is usually recommended only if the clinical or ultrasound findings are suspicious or malignant, or for those who have a strong family history of breast cancer.

35–50 years

  • As per expert consensus opinion, mammography and targeted ultrasound are considered as complementary for evaluation of symptomatic women in this age group.

Over 50 years

  • Mammography is recommended as the first imaging modality.
  • Ultrasound is an acceptable initial investigation if the lump is clinically consistent with a simple cyst and a normal mammogram has been performed in the last year.
  • If the ultrasound does not confirm a typical cyst, further investigation including mammography must be performed.
  • Ultrasound should also be used in addition to mammography to help characterize mammographic abnormalities.
  • If there is a clinical abnormality and either the mammogram is normal or the mammogram is unhelpful, e.g. extensive dense parenchyma

Ultrasound in addition to mammography is considered

  • To guide a fine needle aspiration or core biopsy

In pregnancy or lactation

  • Ultrasound is the most useful modality
  • Mammography should be considered if clinical or ultrasound findings are indeterminate/suspicious/malignant, or if there is inconsistency between test results.

Non-Excisional Percutaneous Biopsy

Fine needle aspiration (FNA) cytology and core biopsy both will have high specificity and sensitivity towards palpable and impalpable lesions.

In a fine needle aspiration biopsy (FNA), a small sample of cells is collected from the lump or area of breast change using a thin needle. This process can be a little uncomfortable but rarely requires local anesthetic. In case if there is difficulty in locating the lump, ultrasound or mammography can be used to guide the physician to place the needle into the right area of the breast.

Fine Needle Aspiration (FNA)

A core biopsy is similar to a fine needle aspiration biopsy, but a larger needle is used. A small cut is made on the women’s skin after applying a local anesthetic and samples of tissue are removed from the lump using a spring loaded core biopsy device. Core biopsy provides a piece of breast tissue rather than just individual cells making it easier for the pathologist to notify the changes.

FNA cytology and core biopsy are alternative to each other, but nothing is appropriate in achieving a definitive diagnosis. Core biopsy can identify invasive disease whereas FNA cannot differentiate between in situ and invasive cancer.

Both FNA and core biopsy can be performed freehand by the breast surgeon if the lesion is palpable, or under image guidance. Ultrasound is preferred for image-guided biopsy because it is a quicker and simpler procedure than mammography and involves no radiation. In cases where the lesions seen on mammography that require biopsy cannot be seen under ultrasound scanner, biopsy can be performed on a special mammographic X-ray machine that allow three dimensional computerized images of the lump to be taken and guide the biopsy needle into the lump. This biopsy procedure is called as Stereotactic Core Biopsy.

How accurate is the triple test?

None of the three tests alone will rule out cancer. However, if triple test is performed more than 99.6% of cancers will be identified (sensitivity 99.6%). Further, triple test may also give false positive result in about 38% of women who have no cancer (specificity 62%). This is because the women classified as ‘indeterminate/equivocal’ in any one of the three components of the test are considered as a positive outcome. A reliable test to detect abnormality should have high sensitivity and thus the false positive rate will be high.

 

The sensitivity of needle biopsy is 90%, less than expected, which is due to sampling techniques i.e. Improper or inappropriate sample of lesion from FNA or core biopsy. The sensitivity of technique increases if biopsy results correlate well with clinical and imaging findings.

Implications for practice

Further investigation may be suggested, in any of the following situations:

  • Where any one component of the triple test is positive i.e.:
    • Clinical examination (suspicious or malignant)
    • Imaging (indeterminate, suspicious or malignant)
    • FNA cytology or core biopsy (indeterminate, suspicious or malignant )
  • Triple Test maximizes diagnostic accuracy while investigation of breast changes.
  • A triple test positive (indeterminate, suspicious, or malignant) is found in 99.6% of breast cancers. Therefore, every positive result requires further investigation of cancer.
  • A triple test negative on all three components provides good evidence that cancer is unlikely (<1%) and further investigation can be avoided for most of these women.
  • A small but significant proportion of breast cancers will not be diagnosed on imaging alone. Therefore, such cases may require biopsy, despite normal imaging findings
  • A single physician should take the complete responsibility of entire investigation and correlate results with the woman’s symptoms.

Open surgical biopsy

Usually, physicians perform ‘Triple test’ to rule out the breast change is cancerous. Sometimes, if the surgeon or radiologist still suspects some abnormality, a FNA or core biopsy might be advantageous. The triple test requires a multidisciplinary approach especially for patients with conflicting results. In such cases, the recommended approach is to proceed with an open surgical biopsy. Previously, prior to the emergence of percutaneous needle biopsies, all breast lumps were subjected to open biopsy. But, nowadays only a very few cases require open biopsy for diagnostic purposes.

Open surgical biopsy is a procedure of examining the whole lump for the presence of cancerous cells. Open biopsy provides accurate information and is performed at a hospital as day surgery under a general anesthetic.
If your breast lump is not felt or it is not a “lump” but something that has been identified only on imaging, its position needs to be marked with a fine piece of wire. Usually, a radiologist does this before the procedure. A local anesthetic is used to numb the skin and then a wire is inserted through a needle guided by a mammogram or ultrasound, called “hook wire localization”. However, some breast surgeons can localize the area if it is visible on ultrasound in the operating room once the patient is asleep, using their portable ultrasound machine obviating the need of pre-operative hook wire localization.

Summary

The Triple Test approach is suggested to maximize the diagnostic accuracy in the investigation of breast changes.

  • Triple test for the assessment of breast symptoms requires a multidisciplinary approach
  • Each component of the triple test plays an important role in identifying the likelihood of breast cancer
  • Triple test shows approximately 100% sensitivity in detection of breast cancer.
  • One clinician must take the responsibility for correlating and interpreting the results of the clinical examination, the medical imaging, and the pathology with women’s symptoms.