ARTICLE IN PRESS

Original Investigation

Breast Imaging Outcomes following

Abnormal Thermography
Colleen H. Neal, MD, Kelsey A. Flynt, MD1, Deborah O. Jeffries, MD, Mark A. Helvie, MD

Rationale and Objectives: The study aimed to determine the outcome of patients presenting for evaluation of abnormal breast thermography.
Materials and Methods: Following Institutional Review Board approval, retrospective search identified 38 patients who presented for
conventional breast imaging following a thermography-detected abnormality. Study criteria included women who had mammogram and/or
breast ultrasound performed for evaluation of a thermography-detected abnormality between January 1, 2000, and December 31, 2015.
Patients whose mammograms and ultrasounds were initiated at an outside institution or who did not have imaging at our institution
were excluded. Records were reviewed for clinical history, thermography results, mammogram and/or ultrasound findings, and pathol-
ogy. Mammograms and ultrasounds were prospectively interpreted by one of 14 Mammography Quality Standards Act–certified breast
imaging radiologists with 3–30 years of experience. Patient outcomes were determined by biopsy or at least 1 year of follow-up. Patient
ages ranged from 23 to 70 years (mean = 50 years).
Results: Ninety-five percent (36 of 38) of patients did not have breast cancer. The two patients diagnosed with breast cancer had sus-
picious clinical symptoms including palpable mass and erythema. No asymptomatic woman had breast cancer. Negative predictive
value was 100%. Of 38 patients, 79% (30 of 38) had Breast Imaging Reporting and Data System (BI-RADS) 1 or 2 assessments; 5%
(2 of 38) had BI-RADS 3; and 16% (6 of 38) had BI-RADS 4 (n = 5) or BI-RADS 5 (n = 1) assessments. Two of six patients with biopsy
recommendations were diagnosed with breast cancer (Positive predictive value 2 = 33.3%). All findings recommended for biopsy were
ipsilateral to the reported thermography abnormality.
Conclusions: No cancer was diagnosed among asymptomatic women. The 5% of patients diagnosed with cancer had co-existing
suspicious clinical findings. Mammogram and/or ultrasound were useful in accurately characterizing patients with abnormal thermography.
Key Words: Thermography; breast cancer; mammography.
© 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

INTRODUCTION cancer screening study in the 1960s. In 1977, Feig et al. com-
pared mammography and thermography screening in 16,000

B
reast cancer is one of the leading causes of death among
women and found thermography to have a sensitivity of 39%
women worldwide. Screening mammography is the
(9). Based on this low sensitivity, Feig concluded that ther-
most thoroughly researched and widely utilized ex-
mography was not practical as a breast cancer screening tool.
amination for breast cancer detection. Screening mammography
Following the results of the study by Feig, breast thermog-
has repeatedly been shown to contribute to decreased breast
raphy was largely abandoned (10).
cancer–associated mortality (1–6). Supplemental screening with
Since that time, thermal imaging technology has im-
ultrasound, tomosynthesis, and magnetic resonance imaging
proved and breast thermography is regarded as an adequate
(MRI) are performed as clinically indicated, especially for higher
method for breast cancer screening in some medical com-
risk women; these imaging modalities have all demonstrated
munities, which describe it as offering earlier breast cancer
effectiveness and safety in the detection of breast cancer.
diagnosis relative to conventional imaging modalities and clin-
However, patients may seek alternative breast cancer screen-
ical examinations (11). Although the US Food and Drug
ing methods such as breast thermography. Less is known about
Administration (FDA) has not approved thermography as a
the efficacy of thermography for breast cancer detection. Breast
stand-alone modality for breast cancer screening or diagno-
thermography was originally developed in the late 1950s in
sis (12), patients concerned with mammographic radiation or
Canada (7,8). Thermography was implemented as a breast
compression may seek thermography in lieu of screening
Acad Radiol 2017; ■:■■–■■ mammography.
From the Department of Radiology, University of Michigan, C415 MIB SPC When a nonpalpable breast abnormality is detected, imaging
5842, 1500 E. Medical Center Drive, Ann Arbor, MI, 48109. Received July 14, guidance is required to localize the abnormality for diagno-
2017; revised September 11, 2017; accepted October 19, 2017. 1Permanent
Address: St. Luke’s Health System Breast Center, 4321 Washington Street Suite sis and treatment. Because thermographic guidance is not readily
1000, Kansas City, MO 64111. Address correspondence to: C.H.N. e-mail: available, patients with thermography-detected abnormali-
hawleyc@med.umich.edu
ties may be referred to conventional breast imaging centers
© 2017 The Association of University Radiologists. Published by Elsevier Inc.
All rights reserved.
for evaluation with mammogram and/or ultrasound. There
https://doi.org/10.1016/j.acra.2017.10.015 is a paucity of literature guiding the radiologist’s approach to

1
NEAL ET AL
patients who present with a clinical indication of “abnormal
thermography.” The purpose of the study was to evaluate the
outcome of patients presenting for abnormal breast thermog-
raphy to provide guidance to radiologists evaluating these
patients.
MATERIALS AND METHODS
Institutional review board approval was obtained for this
Health Insurance Portability and Accountability Act-
compliant retrospective cohort study. No extramural funding
was used. Informed consent was waived. Using institutional
records, we retrospectively identified patients who had the
words “thermogram,” “thermography,” or “thermascan”
included in their breast imaging reports at our institution
between January 1, 2000, and December 31, 2015. After
the data acquisition, the study database was de-identified to
complete the analysis. Our center is a National Cancer
Institute-designated comprehensive cancer center and a
National Comprehensive Cancer Network center. Breast
thermography is not performed at our institution. Forty-
five patients were identified from this records search. The
study population included female patients who were re-
ferred for conventional breast imaging (mammogram and/or
ultrasound) for evaluation of an abnormal thermography
finding. We excluded cases that only referenced thermogra-
phy in the report because thermography was discussed with
the patient (n = 4), included clinical history of recent nega-
tive thermography (n = 1), and cases in which the standard
breast imaging workup for thermography abnormality was
initiated at an outside institution (n = 2). Abnormal thermog-
raphy results were not further classified other than providers’
referral. Thirty-eight patients who were referred for conven-
tional breast imaging for evaluation of a thermography
abnormality composed the patient cohort.
Medical records were reviewed to record data on side of re-
ported thermography abnormality. The prospectively rendered
mammogram and/or ultrasound findings and Breast Imaging Re-
porting and Data System (BI-RADS) assessment category were
recorded (13). The size, laterality, in-breast location of imaging
findings, and whether the patient had a screening mammo-
gram within the 18 months before thermography were recorded.
Patients’ family and personal histories of breast cancer, age,
menopausal status, and years of imaging follow-up were re-
corded. Family history was considered positive if there was a
first-degree relative with breast cancer (i.e., sister, mother, and/or
daughter). Presence or absence of personal history of breast
cancer or prior high-risk lesion (e.g., lobular neoplasia) was
recorded. Presence of concomitant clinical breast symptoms
such as palpable mass or pain was also noted.
In women older than 30 years, diagnostic mammography
+/− ultrasound was performed for evaluation of a clinical
problem at our institution according to National Compre-
hensive Cancer Network guidelines (14). Women younger
than 30 years were initially evaluated with focused ultra-
sound of the area of concern; diagnostic mammogram, if
2
Academic Radiology, Vol ■, No ■■, ■■ 2017
performed, was per radiologist recommendation. Mammog-
raphy may not have been performed based on the patient’s
age or if the patient declined mammogram. Diagnostic mam-
mograms routinely consisted of craniocaudal, mediolateral
oblique, and lateral views, and were performed on either
Senographe DMR systems (GE Healthcare) or Senographe
Essential (GE Healthcare). Additional diagnostic views were
performed at the discretion of the interpreting radiologist de-
pending upon clinical situation. Digital breast tomosynthesis
was not used during the study period. All mammograms were
interpreted by one of 14 Mammography Quality Standards
Act–certified breast imaging radiologists with 3–30 years of
experience. Focused ultrasound was performed by the diag-
nostic radiologist using GE Logiq systems (GE Healthcare).
Ultrasound was commonly performed if the location of the
thermography abnormality was known based on thermogra-
phy report or if a focal mammographic finding such as mass
or asymmetry was identified. If biopsy was performed, biopsy
method and pathological diagnosis were recorded. Patient out-
comes were determined by biopsy or at least 1 year of imaging
follow-up.
RESULTS
Ninety-five percent (36 of 38) of patients who presented for
breast imaging evaluation following abnormal thermogra-
phy did not have breast cancer. The two patients diagnosed
with breast cancer had known co-existing suspicious clinical
symptoms including palpable mass and erythematous breast.
No asymptomatic woman referred for evaluation of a ther-
mography abnormality was found to have breast cancer. Of
the 36 patients without breast cancer, four had a breast biopsy
with benign result and all others had clinical and/or imaging
follow-up of at least 1 year.
The patients’ ages ranged from 23 to 70 years, with a mean
and median age of 51 years. Of the 38 patients, 79% (30 of
38) had BI-RADS 1 or 2 assessments; 5% (2 of 38) had BI-
RADS 3; and 16% (6 of 38) had BI-RADS 4 (n = 5) or BI-
RADS 5 (n = 1) assessments. The two cases with probably
benign BI-RADS Category 3 findings were stable on follow
up for greater than 2 years. Two of six patients with biopsy
recommendations were diagnosed with breast cancer (Posi-
tive predictive value 2 = 33.3%). However, both patients
diagnosed with breast cancer had ipsilateral suspicious clini-
cal symptoms in addition to their reported thermogram
abnormalities; both patients had a preexisting, known palpa-
ble mass and one of the patients had an erythematous ipsilateral
breast. One of the palpable masses measured 15 mm, and the
second patient who was diagnosed with breast cancer had mul-
tifocal palpable masses, the largest measuring 6 cm. This patient
also had erythema and skin thickening involving the inferi-
or half of her breast. Of all the patients, 34% (13 of 38) of
patients had concomitant clinical symptoms in addition to the
reported thermogram abnormality for which they were referred.
Fifty percent (3 of 6) of the conventional imaging find-
ings recommended for biopsy were calcifications and 50% (3
Academic Radiology, Vol ■, No ■■, ■■ 2017 BREAST IMAGING OUTCOMES POST ABNORMAL THERMOGRAPHY

TABLE 1. Suspicious Findings on Conventional Breast Imaging and Outcomes following Abnormal Thermography Results

Imaging
BI- Thermography Mammogram Finding
Age RADS Abnormality Finding Size (mm) Biopsy Method Pathology Result Clinical Symptoms
41 4 Right Right—calcifications 60 Stereotactic Fibrocystic No
54 4 Left Left—calcifications 7 Surgical Fibrocystic No
47 4 Left Left—calcifications 30 Stereotactic PASH No
68 4 Right Right—mass 9 Patient declined N/A—Mass stable No
for 2 years
70 4 Right Right—mass 15 Ultrasound IDC Palpable right breast
mass
48 5 Right Right—mass and Multifocal Ultrasound IDC Palpable breast mass
calcifications and erythematous
breast

IDC, invasive ductal carcinoma; N/A, not applicable; PASH, pseudoangiomatous stromal hyperplasia.

of 6) were masses. All were ipsilateral to the thermography

abnormality. One patient declined biopsy of her suspicious
TABLE 2. Conventional Breast Imaging Results and Patient
finding; however, this finding was stable on follow-up for more Risk Factors
than 2 years. Additional information about the biopsy rec-
ommendations and outcomes can be found in Table 1. Patients Referred for
Both patients diagnosed with breast cancer had invasive ductal Abnormal Thermogram
carcinoma, one of which measured 11 mm at excision and n = 38
Number and (%)
one of which was multifocal. The patient with the 11-mm
of Cases
breast cancer had zero positive axillary lymph nodes at the
time of lumpectomy and sentinel lymph node biopsy. The BI-RADS
patient with the multifocal palpable breast cancer had two ab- 1 26 (68.4)
normal ipsilateral lymph nodes on axillary ultrasound, 2 4 (10.5)
3 2 (5.3)
but—because of widely metastatic breast cancer at the time
4 5 (13.2)
of diagnosis—did not have breast or axillary surgery during
5 1 (2.6)
the 3 years of institutional follow-up. The final number of First-degree family history of breast
positive lymph nodes was not known. cancer
Of 38 patients, 33 (86.8%) had a diagnostic mammogram Negative 35 (92.1)
performed, and five (13.2%) were evaluated with ultrasound Positive 2 (5.3)
only, most commonly because the patient declined mammo- BRCA mutation 1 (2.6)
gram. Of the 33 patients who had a mammogram, 24 (72.7%) Personal history of breast cancer
had scattered areas of fibroglandular densities; 25 (75.8%) pa- Negative 32 (84.2)
tients evaluated with mammogram also had focused ultrasound Positive 5 (13.2)
performed. Of 38 patients, 34 (89.5%) were older than 40 High-risk (LCIS) 1 (2.6)
Menopausal status
years old. Of these, 10 (29%) had a screening mammogram
Premenopausal 19 (50)
within 18 months before the diagnostic evaluation; none of
Postmenopausal 19 (50)
these patients were diagnosed with breast cancer. Neither of Clinical symptoms
the patients with breast cancer had a screening mammogram Yes 13 (34.2)
within 18 months. No 25 (65.8)
The patient population was composed primarily of women Mammogram density n = 33
at average risk for breast cancer. The majority of patients 92.1% Almost entirely fatty 2 (6.1)
(35 of 38) did not have a first-degree family history of breast Scattered areas of fibroglandular 24 (72.7)
cancer or family history of known genetic mutation. Six of densities
38 (15.8%) patients had a personal history of breast cancer or Heterogeneously dense 6 (18.2)
prior high-risk lesion; one patient had a prior history of lobular Extremely dense 1 (3)
carcinoma in situ. Additional information regarding patient BI-RADS, Breast Imaging Reporting and Data System; LCIS, lobular
risk factors and demographic data can be found in Table 2. carcinoma in situ.

3
NEAL ET AL
DISCUSSION
We found that no asymptomatic women were diagnosed with
breast cancer when referred for conventional breast imaging
for a reported thermography abnormality. The two patients
who were diagnosed with breast cancer had co-existing sus-
picious clinical symptoms. To our knowledge, this study is
the first to examine the outcome of patients presenting for
conventional breast imaging evaluation of a breast thermog-
raphy abnormality.
Thermography is a technique used to convert infrared ra-
diation emitted from the body into electrical impulses that
are displayed on a monitor in various colors (15). The spec-
trum of colors indicates an increase or decrease in the infrared
radiation or temperature being emitted from the body surface.
An abnormality detected by thermography indicates an area
of temperature asymmetry in the body. Based on patterns of
heat and blood flow on or near the surface of the body, ther-
mography has been utilized in an effort to detect, characterize,
and monitor multiple disease processes. The American College
of Clinical Thermology’s (ACCT) website lists 76 clinical in-
dications for thermographic evaluation, primarily for benign
neurological and musculoskeletal disorders (16). Thermog-
raphy has also been used to evaluate breast disease and proposed
for the detection of breast cancer. However, both benign and
malignant processes may increase local vascularity and cause
variations in temperature, limiting the specificity of
thermography.
The first breast thermography was performed in 1956 by
a Canadian surgeon, Dr. Ray Lawson, who noted that pa-
tients with breast cancer had a higher skin temperature than
other patients (8). In the subsequent years, Lawson contin-
ued to develop the infrared imaging instrument he called
Thermoscan (7). The device was used for breast cancer de-
tection in the 1960s and 1970s. However, in 1977, based on
an analysis of 16,000 women in the Breast Cancer Detec-
tion and Demonstration Project, Feig et al. found that breast
thermography had a low sensitivity of 39% (9), limiting its
utility as a breast cancer screening modality.
As thermography technology has improved, some medical
providers maintain that it may still be a reliable breast cancer
screening tool. In 2011, the FDA reported that “some health
care providers claim thermography is superior to mammog-
raphy as a screening method for breast cancer because it does
not require radiation exposure or breast compression” (12).
The FDA has not approved breast thermography as a stand-
alone modality for breast cancer screening or diagnosis. The
FDA has also sent warning letters to multiple providers in-
structing them to cease “making inappropriate claims about
thermography devices” because women may believe “mis-
leading claims about thermography and not receive needed
mammograms” (17). In 2012, the Canadian government also
released a statement advising that “no thermography ma-
chines have been approved to screen for breast cancer. Health
Canada is not aware of any clinical evidence that thermog-
raphy can be used effectively as a screening technique. . .” and
4
Academic Radiology, Vol ■, No ■■, ■■ 2017
that thermography “. . .may present a potential risk to women
relying on the results” (18). Nevertheless, women continue
to seek breast thermography, either as a stand-alone screen-
ing modality or as a supplement to mammography. A recent
review of the ACCT website showed that there are over 600
facilities approved by the ACCT to perform thermography
in the United States (19).
Several authors have reported potential benefits of breast
thermography (20–23). For example, in 2008, Arora et al. re-
ported that digital infrared thermal imaging (DITI) had up
to 97% sensitivity for breast cancer detection (21). However,
the study patients were selected from an apparent enriched
patient population with suspicious mammographic lesions
already recommended for biopsy, without clear delineation
of how the readers were blinded to the correlative mam-
mography and pathology results. The authors found a low
specificity, 11% in the screening mode, which would limit
the feasibility of DITI as a screening test. Wishart et al. found
a low sensitivity (53%), specificity (41%), and negative pre-
dictive value (36%) when the Digital Infrared BreastScan itself
assigned “risk scores” in a screening mode; these parameters
increased to 78%, 48%, and 59%, respectively, when the images
were also reviewed by an expert image reviewer (22). However,
the expert readers were not blinded to the biopsy site. These
recent investigations of DITI demonstrated suboptimal results
for breast cancer screening when compared to the perfor-
mance of digital screening mammography. For example, in
a recent investigation, digital screening mammography had
a sensitivity and a specificity of 87.3% and 91.4%, respec-
tively (24). Others have questioned thermography as a breast
cancer screening tool (9,25–29). These authors noted that ther-
mography had poor reproducibility (28), suboptimal sensitivity
and specificity (9,25–27), and had no evidence of reduced mor-
tality (29).
In clinical practice, it is relatively common to have pa-
tients referred for conventional breast imaging with
mammography and/or breast ultrasound following detec-
tion of a breast abnormality on cross-sectional imaging such
as CT, MRI, or positron emission tomography (PET) per-
formed for nonbreast indications. Outcomes of breast lesion
detection with these cross-sectional imaging modalities have
been reported. A 2007 publication by Meller et al. found that
1% of the CTs included in the study had an incidental breast
finding; of those findings, 50% were found to be breast cancer
(30). More recent publications of incidental lesion detection
on CT have reported that the rate of breast cancer ranges from
28% to 31% (31,32). A recent publication of the outcome
of incidental breast lesions detected on body MRI found that
11% of the lesions were proven to be breast cancer (33). In-
cidental abnormal breast lesions referred after PET scan also
have a high probability of breast cancer, ranging from 29.7%
to 57% (34–36).
We are not aware of literature that has examined the
outcome for patients referred for breast imaging evaluation
with the clinical history of abnormal thermogram. We found
that 95% of the patients referred for thermography abnor-
Academic Radiology, Vol ■, No ■■, ■■ 2017 BREAST IMAGING OUTCOMES POST ABNORMAL THERMOGRAPHY
mality did not have breast cancer (Fig 1). No asymptomatic
patients were diagnosed with breast cancer. Based on our results,
the probability of an asymptomatic patient with abnormal ther-
mography of having breast cancer is much lower than that
of PET, CT, or MRI. Conventional breast imaging had a 100%
negative predictive value in our small series and appears suf-
ficient to reasonably manage these patients. This information
may be useful to practicing breast imagers to familiarize them-
selves with outcome expectations when patients are referred
because of abnormal breast thermography.
Limitations of our study include those inherent to a ret-
rospective design, case selection of referred patients, and low
numbers of patients. We considered the thermogram to be
abnormal solely based on the outside thermography report
without further characterization of the findings, a situation
expected to be encountered among conventional breast imagers.
There were three patients who had between 1 and 2 years
of follow-up, and we acknowledge that radiological or patho-
logical follow-up of less than 2 years is suboptimal. With this
limitation in mind, we note that none of the patients who
Figure 1. (a) Breast thermography image
from a 33-year-old female. The reported
thermography abnormality was a “hyper-
thermic, complex, and vascular-like pattern
in the cranial left breast” (seen as areas of
yellow, orange, and red in the contour of
the upper left breast). This is the thermog-
raphy abnormality that prompted the patient
to present for evaluation with convention-
al breast imaging. (b) The patient’s left
mediolateral oblique mammogram was neg-
ative. Focused ultrasound of the upper left
breast was negative, as seen in (c). No
cancer was detected at 3 years of follow-
up. (Color version of figure is available
online.)
had abnormal thermography, negative conventional breast
imaging, and longer follow-up were found to subsequently
have breast cancers; there were no false-negative mammo-
grams and/or breast ultrasounds.
In conclusion, patients may be referred for breast imaging
with mammogram and/or ultrasound after abnormal ther-
mography. We found that the large majority of patients with
abnormal thermography had negative conventional breast
imaging and that no asymptomatic patients had breast cancer.
However, a small percentage of patients with abnormal ther-
mography may be diagnosed with breast cancer. Therefore,
a presenting history of abnormal thermography should be evalu-
ated with thorough review of clinical history, physical
examination, and age-appropriate mammogram and/or
ultrasound.
ACKNOWLEDGMENTS
We thank Lisa Robbins for help in manuscript preparation.
5
NEAL ET AL
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