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Breast cancer screening and diagnosis has continuously improved over the past 30 years. Physicians now
have a clinical decision tree for detecting and diagnosing breast cancer that has been refined
to a high level. Click here for more information
on the breast cancer diagnosis decision process (note, T-scan imaging is used in the "recalled
for further views" portion of the decision process).
T-scan is an adjunctive tool that may be used in combination with screening and diagnostic
mammography,
ultrasound imaging
and breast biopsy. T-scan may help physicians
decide which women need a biopsy when their mammograms alone don't give enough information.
A physician or radiologist may refer a woman for a T-scan after mammography is performed, if a
suspicious region is detected with mammography or physical examination. Please note, T-scan
breast imaging is presently available at only 36 locations worldwide (see the section Where
is T-scan Available). As T-scan becomes more
widespread, more patients may be referred for breast imaging with the electrical impedance technology.
T-scan imaging is approved by the US Food and Drug Administration (FDA) for use as an adjunct
to mammography for the diagnosis of breast cancer. The FDA has determined that T-scan is
safe for women. T-scan imaging has been documented in clinical testing with over 20,000
women without an adverse reaction.
Yes. T-scan imaging is a completely
different imaging modality and its ability to spot cancers has no connection with the
lesions radiologic visibility. Clinical sources report that approximately 10% of
cancers are occult (invisible) on mammography. Other lesions may be visible on a mammogram
upon close inspection by a trained radiologist or physician, but very difficult to
identify because of a variety of factors, such as density of breast tissue, texture, image
artifacts, or film quality. Therefore, additional modalities, such as impedance imaging,
can be useful complements in the quest to find breast cancers early and accurately. If the
T-scan result is positive, it is recommended that the mammogram be reviewed again or an
ultrasound performed.
Microcalcifications (tiny calcium
deposits) may be a byproduct of malignant cells. Microcalcifications are not electrically
distinguishable with T-scan imaging at the scanning frequencies used. However, T-scan does
detect the electrical changes associated with the malignant cells. Hence T-scan imaging
can potentially image and "see" cancers that on mammography are visible only as
microcalcifications.
One limitation of T-scan is that is can sometimes yield false-positive results. That is, the T-scan will indicate
cancer when cancer is not present. Researchers believe that the rate of false-positive results with T-scan imaging
seems to be correlated to hormone status. In young, pre-menopausal women, the rate of false positives is correlated
with estrogen levels over the menstrual cycle. Therefore, the best time for an impedance imaging examination in order
to minimize false positive results is the second week after the start of the woman's period.
Similarly, the rate of false positive results is affected by taking hormone replacement
therapy (HRT) after menopause. In this case, timing
of the examination does not influence results. Finally, atypical
hyperplasia (atypia) may appear as a
positive T-scan finding. Atypia is a pre-cancerous lesion and so its presence is important clinical
information since women with atypia are at a higher risk of developing cancer.
Small, active cancers (less than 1 cm) are often more readily visualized with T-scan imaging than
are large, palpable lesions (greater than 2 cm). Lesions as small as 1 mm have been reliably
visualized using T-scan imaging. This may be because large tumors have more fiber content that
may reduce their electrical "visibility." Also, small tumors may differ from large tumors in a
number of biochemical factors (for example, steroid hormone receptors) that may affect their
electrical properties. In general, the earlier breast cancer is found, the greater the chances of survival.
No specific patient preparation is
required for T-scan imaging. Women are encouraged to wear a two piece outfit so that they
only have to remove their top and bra for the T-scan examination: a blouse which buttons
in the front is optimal since it can be easily removed, while pullover tops are less
convenient.
The T-scan imaging exam produced images
in real time. T-scan image acquisition takes a few seconds per quadrant. The entire T-scan
imaging procedure generally can be performed in approximately 10-15 minutes.
Because the voltage used with T-scan
imaging is very low (like holding a small flashlight battery), the patient is not
subjected to discomfort. Although most women feel nothing, some women who are very
sensitive feel a slight tingling in the hand.
A woman's physician or the mammographer
radiologist will determine which patients should be examined with T-scan imaging after
mammography. The American College of Radiology (ACR) has established the Breast Imaging Reporting and Database System (BI-RADS)
to guide the breast cancer diagnostic routine. Multi-center international studies have
shown that T-scan imaging is very useful in distinguishing cancers from benign lesions in
the BI-RADS 3 (probably benign, recommended for six month follow-up) and BI-RADS 4 (likely
suspicious, recommend for biopsy). Cases with clear indications of malignancy (e.g.
linear, branching, clustered punctuate or pleomorphic calcificiations, masses with
ill-defined or spiculated borders, clear architectural distortion, suspicious palpability)
should be referred directly for biopsy.
Patients with pacemakers should not
receive T-scan imaging because the electrical frequencies at which the system operates may
interfere with the pacemaker. The device has also not been tested on pregnant patients,
and is therefore not advisable for this group.
Breast ultrasound
is also used as an
adjunctive tool with mammography. Breast ultrasound can be particularly useful to
characterize lesions, such as determining solid versus cystic (fluid filled) masses.
However, ultrasound's sensitivity is limited by tumor size. Ultrasound detection of tumors
smaller than 1 cm in size may be difficult. However, detection of small breast tumors is
extremely important because that is when treatment is most effective. T-scan imaging works
particularly well in identifying this class of small tumors.
Estimates show that T-scan imaging
should add less than $100 to the cost of the breast cancer diagnosis process. Government
and insurance reimbursement guidelines and codes do not exist at present but are in the
process of being established.
The T-scan imaging system shows much
promise in being used for follow-up with patients who are being treated for breast cancer.
Patients undergoing chemotherapy and/or radiation therapy, and patients who have just
experienced surgery are not immediately candidates for mammography. However, T-scan
imaging can be used to visualize the presence/disappearance and intensity of the lesion.
Further clinical work will be done to establish T-scan imaging as a tool for following the
course of breast cancer treatment.
Updated: October 31, 2000
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