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FDA Information
K032350
Trade/Device Name: Infrared Sciences BreastScanIR* System
Reg. Number: 21 CFR 884 2980
Reg. Name: Telethermographic system
Reg. Class: 1
Product Code: 90 LHQ
Indications for Use:
The Infrared Sciences BreastScanIR System is intended for viewing and
recording heat patterns generated by the human body in the hospital,
acute care settings, outpatient surgery, healthcare practitioner facilities
or in an environment where patient care is provided by qualified
healthcare personnel. The patient population includes
adults. The device is for adjunctive diagnostic screening for
detection of breast cancer and diseases affecting blood perfusion or
reperfusion of tissue or organs. This device is intended for use
by qualified healthcare personnel trained in its use.
Frequently Asked Questions
How is Sentinel BreastScan
different from the “thermography” of the past?
Many doctors are aware of the past efforts to use
“thermography” in detecting breast cancer. The
earliest investigations can be traced back to the 1950’s.
These early efforts, had varying degrees of success, wherein the
effectiveness of the test was limited by two primary factors. The
first was the sensitivity of the measurement device, and the second was
the expertise of the doctor in “reading” the images.
Despite these limitations, some doctors and researchers
were able to demonstrate test effectiveness and have documented these
results in numerous publications.
The Sentinel BreastScan system is unique, and unlike any system
utilized in the past. It is the first of its kind, where there is
no “reading or interpretation” of images, and it utilizes
the most advanced infrared camera and software technology available
today. It further differs in that it provides a fully objective
test report in “real-time” to the doctor, and it does not
require a specially qualified operator to conduct the test. The
operator need not possess more knowledge than how to properly operate a
computer mouse.
Because the Sentinel BreastScan is objective and under full computer
control its results are very repeatable. The report output cannot
be influenced by the operator, and the computer self-tests the data to
determine if it was recorded properly. The system even stores all
operator input including mouse movement, so that a test can be repeated
or re-analyzed. Repeatability allows the Sentinel BreastScan to be used
for establishment of a baseline, and then for comparison in future
infrared studies.
Have there been any published
studies on infrared imaging for breast cancer detection?
There are approximately 800 published studies on infrared imaging
involving over 300,000 women by some estimates. ISC has published
two papers on the Sentinel BreastScan and its test results in the IEEE
Engineering in Medicine and Biology Conference in both 2003 and 2004.
The best summary of these early studies with references can be
found at www.breastthermography.com. You can also find the ISC
studies published at IEEE EMBC 2003 and 2004 in the
"Publications" Tab above.
Is infrared FDA approved for
this purpose? Is the Sentinel BreastScan system approved too?
The efficacy of infrared imaging for adjunctive breast cancer screening
was demonstrated to the FDA’s satisfaction in 1982. Since then,
all systems that are used for this purpose are given an FDA 510k
clearance, under CFR 21 884.2980. The Sentinel
BreastScan system received its clearance in February 2004.
Is infrared able to detect
cancer early? What does infrared detect?
Numerous studies have shown that infrared can detect the signs of
developing cancer years before modalities such as mammography; by up to
10 years, and that it is a good indicator of risk for breast cancer.
Infrared is able to detect the physiologic changes that are often
associated with developing disease, as well as the detection of
neo-angiogenesis (new blood vessels that develop to feed cancerous
tumors). Much of the past and current uses of this technology
made measurements that, in one way or another, assessed the differences
when comparing both breasts. Symmetry between breasts is one of
the most telling signs that can be measured and quantified by the Sentinel
BreastScan system. The determination of areas within the
breasts that show a high degree of blood perfusion, or vessels that may
be angiogenic, are also of importance. ISC has developed
proprietary software that locates these areas accurately, and is able
to assign a value for the degree of abnormality. In nearly 100%
of cases where there was a localized cancer (excluding inflammatory
breast disease which may involve the whole breast), the Sentinel
BreastScan has accurately identified the location. A doctor using
this “road map” of sites that exhibit abnormal signs, can
then make a very thorough evaluation of the area. In some cases where
these sites are within dense tissue and a proper assessment cannot be
made by mammography, other modalities, such as ultrasound or MRI, may
be indicated.
Is infrared a good predictor
of risk?
One of the best studies on infrared as a predictor of risk, was
published in 1983 by Gauthrie, ( Pasteur Institute , France).
This Study took a look at several hundred women spanning a 10
year period of systematic follow-up. Three groups of patients
were selected, each patient having initially healthy breasts:
Control Group n=486
Patients with primary family history of BC and with a normal thermogram
Study Group 1 n=31
Patients with primary family history of BC and with an abnormal
thermogram
Study Group 2 n=106
Patients without primary family history of BC and with an abnormal
thermogram.
This Study showed astonishing results. In ten years, 3.9% of the
Control Group patients were diagnosed with breast cancer, contrasted
with 36% and 27% for Study Group 1 and Study Group 2, respectively.
In fact, the Study showed that 32% and 25% of Study Group 1 and 2
respectively, developed cancer within 3 years.
This fact clearly shows that primary family history is not as robust an
indicator of risk, as is an abnormal infrared. Studies
have concluded that an abnormal infrared is 10 times better an
indicator of risk than a primary family history.
Does infrared imaging form a
good baseline test for comparison with future infrared testing?
How early can infrared detect the signs of breast cancer?
Since the Sentinel BreastScan is fully objective, and always utilizes
the same analysis techniques for every person every time, it is very
useful for establishing a baseline report for comparison to future
reports. This will allow the doctor to monitor for changes, which may
be an advance warning for development of disease. Since infrared
has been shown to detect these signs up to 10 years in advance, the
patient and doctor can plan a careful program for follow-up testing or
monitoring, and ample time to correct any lifestyle risk factors
(smoking, obesity, HRT, etc.).
How many patients have been
tested with the Sentinel BreastScan system?
Infrared Sciences started the development of the Sentinel BreastScan
system in 1999, and since that time has tested over 2500 female
patients. This testing took place in two mammography facilities,
and one oncology center, over the years spanning 1999 to the present.
The patients, ranging in age from 35 to 80 years were included in
our studies. They comprised three groups; those believed cancer free,
those with newly discovered cancer, and those who previously had a
diagnoses of cancer. The first group consisted of
approximately 2300 patients with no known cancer
(presumed normal). The second group was
comprised of approximately 100 patients
with newly detected, biopsy proven cancer, and
the third group included approximately 70
patients who underwent treatment (includes any combination of
surgical, chemo, or radiation) for proven malignancy
0 to 10 years previously. Included in the
cancer cases, were three cases undetectable by mammography
alone and were found only on
ultrasound examination. Various types
of malignancy were represented in our sample,
including, DCIS, LCIS, invasive ductal carcinoma,
invasive lobular carcinoma, and inflammatory
carcinoma; in some cases with lesions as small as 4 mm.
What is the sensitivity of
the test? What about false positives?
Infrared imaging is approved for use as an adjunctive test in breast
cancer detection and screening. It is NOT a diagnostic test . In fact,
mammography, ultrasound, MRI, CT, etc. are also NOT diagnostic tests .
None of these imaging tests have the ability to diagnose cancer. Only a
biopsy can answer this question.
Any test that is to be used in a screening role should have a
sensitivity as high as possible. The sensitivity of a test is to
insure there are no “false negatives”, i.e. missed cancers.
In order to determine the sensitivity of a test it is necessary
to conduct studies on positive patients whose outcome is known (or
becomes known thereafter). Simply, all of the patients in a Study need
to have a biopsy, and the pathology determined with a high degree of
accuracy. This allows the test’s sensitivity to be
determined as the percentage of correct positive determinations. The
Sentinel BreastScan continues to demonstrate a sensitivity of over 98%.
Questions are often asked about “false positives” in
infrared imaging. The false positive rate is a measure of a
test’s “specificity”, and a diagnostic test should
have a specificity as high as possible. The specificity of a test
is to insure there are no “false positives”, i.e. cancer
being indicated when none is observed or found.
Sensitivity and Specificity are two parameters that are often the
inverse of one another, and rarely is there a test that exhibits
outstanding performance in both categories simultaneously. There are no
tests like that for screening of breast cancer.
Mammography, being the only stand-alone FDA approved screening test, is
only fair for women with “fatty” breast tissue, and is poor
for women with “dense” breast tissue.
Infrared imaging is unique among breast cancer tests, in that it is the
only one with prognostic qualities, i.e. predictive ability. That
being the case, it is inappropriate to measure specificity, or
“false positives”, except in a very general way.
Since infrared can warn of disease 10 years before current
modalities can detect it, today’s “false positive”
can become tomorrow’s “true positive”, so what is it
properly called today? It is for this reason, a test that is
prognostic should not have its specificity measured except over an
appropriately long time frame. Infrared imaging has been
estimated to be about 65% specific over the span of 10 years. (this can
be derived from the Gauthrie Study discussed above). The Sentinel
BreastScan specificity is measured at just over 50% on an immediate
time scale (i.e. not over time). We fully expect our test’s
specificity over time, to meet or exceed the performance of the
previous Studies, however we do not yet have data on a fixed cohort of
patients. This will be evaluated in the coming years. Any doctor
that commences using the Sentinel BreastScan on his or her patients
could be added to the source for the answer to the question.
Suffice to say that it is the opinion of those doctors expert in this
area that about 25-30% of women should test positive on their initial
infrared report. Only 8% of women fail the Sentinel
BreastScan exam with a highly abnormal report, and with no immediate
cancer detected. It is believed that this group will be those
that make up the population of women, of which 30-35% will get cancer
within 10 years. A patient that finds themselves in this category
may experience additional anxiety. This is unavoidable; however consider
that most women already believe they are at risk for breast
cancer. This additional piece of breast health/risk data will
allow the woman and her doctor to exercise the most rigorous monitoring
program in order to detect the cancer at its earliest treatable size,
This is significant considering the cost in lives saves along
with the conservation of breasts. And with this level of advanced
warning, early lifestyle changes combined with preventive treatment may
be able to change the course of the disease. A positive infrared
finding, when no cancer is detected serves as a “clinical
marker” for the doctor and patient. No earlier detection
can be made when being armed with the data that infrared imaging can
provide, and watching as closely as possible with every detection
modality at your disposal.
What are the risks to the
patient? Is there any radiation?
The Sentinel BreastScan test is completely non-invasive and poses no
risks whatsoever to the patient. The system does not emit any
harmful radiation, but instead measures the infrared radiation
that naturally emanates from the human body. Additionally, there
is no contact with the patient thus, no compression of the breasts is
needed. During the administration of the test, the patient sits,
disrobed from the waist up, in a chair facing the Sentinel BreastScan
equipment suite. Once the automatic test sequence is commenced,
the computer controls all aspects of the test. During the
4-minute recording phase, cool air is directed at the breasts.
After recording, the patient is free to leave, and the operator
completes the analysis of the data thereafter. The entire process takes
about 5 minutes.
Who can benefit from infrared
testing? Does this test diagnose cancer and replace
mammography? Is this test useful for young women that do not yet
receive mammography?
Simply, all women can benefit from infrared imaging for breast cancer
detection (including pregnant women and those breastfeeding). It
is an adjunctive test that does not diagnose cancer, and is not a
replacement for mammography.
Infrared imaging can supplement the Clinical Breast Exam (CBE) by the
patients doctor, if the women is not yet of age to receive a
mammography. Infrared imaging is a useful adjunct for
women with dense breast tissue, where mammography is ineffective, and
especially true in young women.
The Sentinel BreastScan test helps the patient’s doctor assess
the overall breast health, and will serve as a clinical marker for the
doctor to utilize in the examination of mammography, ultrasound, MR, or
CBE, data. Based on the excellent negative predictive
value demonstrated in our studies, and combined with the low prevalence
of the disease, it is likely that any patient that tests negative with
the Sentinel BreastScan, has that extra degree of assurance that
“nothing was missed”.
What recommendations might be
made by the patient’s doctor following an abnormal infrared test
in a young woman?
There are several areas that have been touched upon in the above
answers for women in general. The fact is that this decision lies
with the patient and the doctor however the use of the Sentinel
BreastScan data can be an influencing factor.
If a patient is of high risk, follow up testing is indicated with non-invasive
tests being on the front line. This testing can be as simple as a
very thorough CBE, or as involved as a breast MRI. Ultrasound, also
non-invasive, may be utilized however with the understanding that
the most prevalent breast cancer, DCIS, is not normally detected by
this modality.
Clearly, just the knowledge that one is demonstrating additional risk
with an abnormal infrared report is useful in itself. Changes in
lifestyle, improved frequency of CBE or BSE (breast self exam), or
close monitoring, are all courses of action that can help avoid or
detect the disease early. As previously stated, there can be no
earlier detection than to know whom to watch, and where in the breast
to focus on.
What about insurance
reimbursement?
Centers using this technology have found that insurance reimbursement
is highly dependent on the patient’s specific policy
restrictions. With this in mind, most centers require payment at
the point of service and provide patients with simple billing sheets
for them to mail to their carrier. Fees charged by doctors for
infrared imaging are set by the individual doctor and vary over a range
from $100 to $350, as determined by a search of available information
on the Internet.
NOTE:
*Sentinel BreastScan is also referenced as BreastScanIR.
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