Improving Efficacy of Breast Disease Detection

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Improving Efficacy of Breast Disease Detection
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• Each year, more than 170,000 women are diagnosed
  with breast cancer in the United States alone,
  and it is the most common form of cancer found in
  women worldwide.
• The average lifetime risk of breast cancer in a
  female infant born in the United States in the
  year 2000 is 12 percent, or one in eight.
• The most common cause of malpractice litigation
  is the missed or delayed diagnosis of breast
  cancer. Clearly, breast disease is a major
  concern for women, and it has a substantial
  effect on both individual and societal health
  care resources.

Diagnosis and Management of Specific Breast
Abnormalities Evidence Report/Technology
Assessment Agency for Healthcare Research and
Quality Department of Health and Human
Services 2101 East Jefferson Street Rockville, MD
20852 September 2001
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From 1998-2002, the median age at diagnosis for
cancer of the breast was 61 years of age3.
Approximately 0.0 were diagnosed under age 20
2.0 between 20 and 34 10.7 between 35 and
44 22.2 between 45 and 54 22.2 between 55
and 64 20.7 between 65 and 74 16.7 between
75 and 84 and 5.6 85 years of age.
Younger women present due to pain or palpation of
lump Older women more likely to participate in
screening mammography
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Recommendations Health and Human Services Agency
US GOV.
The best available evidence suggests that breast
symptoms are evaluated initially by clinical
breast exam and imaging study, with supplemental
studies when the diagnosis is unclear. There is
no evidence to support modifying the work-up of
breast symptoms or mammographic abnormalities
based on risk factors other than age The
MetaWorks investigators Agency for Healthcare
Research and Quality (AHRQ) Diagnosis and
Management of Specific Breast Abnormalities Eviden
ce Report/Technology Assessment Agency for
Healthcare Research and Quality Department of
Health and Human Services
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RISK INDEX The primary categories of
RISK Family History 1 or 2 first degree
relative Previous biopsy Estrogen
Therapy Nulliparitous (no live
births) Age Meta analysis revealed No
indicator other than AGE was significant for
demonstration of breast cancer
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• The most common cause of malpractice litigation
  is the missed or delayed diagnosis of breast
  cancer. Clearly, breast disease is a major
  concern for women, and it has a substantial
  effect on both individual and societal health
  care resources.

The MetaWorks investigators Agency for
Healthcare Research and Quality (AHRQ) Diagnosis
and Management of Specific Breast
Abnormalities Evidence Report/Technology
Assessment Agency for Healthcare Research and
Quality Department of Health and Human Services
7
Future research also should be undertaken to
identify additional or new risk factors. If all
of this information were available, a
comprehensive assessment of risk could be
calculated. This, in turn, could lead to
development of a risk model that could be used by
doctors and patients to assess breast cancer
risk. Such a model could be an adjunct to models
(such as the Gail model) that currently are in
use, and it could include not only risk factors
but also breast symptoms and mammographic
findings.
The MetaWorks investigators Agency for
Healthcare Research and Quality (AHRQ) Diagnosis
and Management of Specific Breast
Abnormalities Evidence Report/Technology
Assessment Agency for Healthcare Research and
Quality Department of Health and Human Services
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What We Do Know.

• Based on Statistical Data
• And large study populations

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Approx 1/3 of Breast Cancers are found in lt50 age
range Average tumor doubling time 6 to 8 years
to 1cm Average life span - 5 years after
detection Every woman dying at age 50 probably
started developing her cancer 13 years earlier or
approx age 371 Dense breasts of those under 50
yrs old less likely detection with
mammography Addition of Infrared screening 95
efficacy of detection combined with
mammography2 1The Initial 1983 Hobbins 2 Dynamic
telethermography of 2,200 breast cancers by R.
AMALRIC, H. BRANDONE, F. ROBERT, C. ALTSCHULER,
J.M. SPITALIER J. INGRAND, J. DESCHANEL Cancer
Institute, Marseilles (France)
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2,226 mammary cancers considered as a
whole, that is through all clinical stages. We
will note that D.T.T. was clearly positive in 71
of cases, suspicious in 2O only and
falsely-negative in 9 .
Dynamic telethermography of 2,200 breast
cancers by R. AMALRIC, H. BRANDONE, F. ROBERT, C.
ALTSCHULER, J.M. SPITALIER J. INGRAND, J.
DESCHANEL Cancer Institute, Marseilles (France)
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Infrared thermograms especially, have made
possible the detection of 217 sub-clinical or
infra-radiological cancers, 25 of which were non
palpable. The false-positives of infrared
thermography do not exceed 10 which makes the
method sufficiently reliable to be used
systematically in the framework of non invasive
diagnosis of breast turmours.
Dynamic telethermography of 2,200 breast
cancers by R. AMALRIC, H. BRANDONE, F. ROBERT, C.
ALTSCHULER, J.M. SPITALIER J. INGRAND, J.
DESCHANEL Cancer Institute, Marseilles (France)
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Combined data from five population
studies Abnormal infrared thermograms of the
breast are called isolated when they are not
accompanied by other clinical or paraclinical
abnormalities. They occur in asymptomatic women
systematically examined or in women consulting
for symptoms other than palpable nodules. Their
incidence is about 10-15. They are usually
considered False Positive Regular follow-up
found cancers occurred with a range of 5
to 38. False Postive thermograms imply high
risk.
The future of women with isolated abnormal
infrared Thermograms of the breast. 1981 Nouv
Presse Med Amalric R, Gautherie M, Hobbins WB,
Stark A, Thierree RA
23 in 10 yr period 4-yr period
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High-Risk Population Studies indicate that the
abnormal thermogram is the only consistent
indicator of conversion to cancer 1,2,3
1 The MetaWorks investigators Agency for
Healthcare Research and Quality (AHRQ) Diagnosis
and Management of Specific Breast
Abnormalities Evidence Report/Technology
Assessment Agency for Healthcare Research and
Quality Department of Health and Human Services 2
Application of Second Generation Infrared Imaging
and Computerized Image Analysis to Breast Cancer
Risk Assessment. Proc. IEEE Eng. Med. Biol.
181019-1021, 1996 3 Breast Thermography Is a
Noninvasive Prognostic Procedure That Predicts
Tumor Growth Rate in Breast Cancer Patients. Ann
New York Acad. Sci. 698 153-138, 1993
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HIGH RISK PATIENT By History and Thermography
No currently known Breast CA
Anterior Image Pre
Anterior Image Post
Anterior Image Pre Challenge Level Enhanced
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HIGH RISK PATIENT By History and Thermography
No currently known Breast CA
Pre Challenge Images
Post Challenge Images w/ increased vascular
response RUOQ R TH5 L TH2
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RISK-Abnormal Infrared Scans stand alone as an
independent Marker for women who are at-risk for
breast cancer. PROGNOSTIC Indicator- The strong
relationships of thermographic results and three
growth-related prognostic indicators suggest
that breast cancer patients with abnormal
thermograms have faster-growing tumors that are
more likely to have metastasized and to recur
with shorter disease-free interval.
TNM
The Important Role of Infrared Imaging in Breast
Cancer Head JF, Wang F, Lipari CA, Elliott
RL IEEE Eng in Medicine and Biology May/June 2000
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Needle biopsy of lump between the 4th and 5th
intercostal space, medial to nipple, 5 mo
previous to this image -- diagnosed as fatty
tumor. Lump persisted in growth, pt. went for
2nd opinion and lumpectomy preformed 7 days ago.
Results were given as invasive ductal carcinoma.
Radical mastectomy is scheduled.
6 mo following mastectomy high risk for
re-occurrence
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Develop protocol that encourages Infrared
Imaging Of women under 50 as part of a full
screening process Monitoring singles out high
risk group for faster intervention with new
procedures or early treatment options Provide
data for blinded comparison over time Conversion
information will back or refute current
statistics
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What Can Be Done
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NEW APPROACHES TO IMAGINGDR. MITCHELL SCHNALL
In the past 15 years, a number of advances in
breast imaging have occurred, the majority of
which are computer-based. These can detect small
changes in breast tissue and areas of vascular
engorgement, which is often associated with areas
of cancer.
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC
HEALTH SERVICE NATIONAL CANCER INSTITUTE 122nd
NATIONAL CANCER ADVISORY 2 001
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Increase Participation in Breast Health
Programs Screening Exam for Baseline
Breast Exam Younger Female High Risk
Population Pre Op Augmentation Pre Op
Breast Lumpectomy Mastectomy Follow-up to
Equivocal Mammography Pre and Post Radiation
treatment
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Recommendations to reduce Morbidity, Mortality
and Costs Related to Breast Cancer

• Digital Imaging w/high-quality imagers with more
  detector elements and greater dynamic range
• Along with
• quantification of infrared abnormalities
• Allows for both quantitative and objective
  analysis.
• Cancer risk assessment with a second generation
  infrared imaging system
• Head JF, Lipari CA,Wang F, Elliott RL
• Infrared Technology and Applications XXIII SPIE
  1997

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THE ANSWER
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• Trillennium Model
• Provide Highest Quality IR Systems
• Reduce Up-front Cost for Clinical Analysis
• to provide Non-Contact Non-Invasive screening
• to women of all ages
• Provide on-going state-of-art technology for
• Statistical Data Collection

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Trillennium Model Allows Clinics to

• Meet Demands of Female Population
• Reduce service cost for clinic and client
• Increase revenue stream for clinic by
  increasing population for Breast Health Programs

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1 Healthy Woman
PRICELESS