Role of DaTSCAN and clinical diagnosis

in Parkinson disease
http://www.uni-kiel.de/medinfo/material/seminar_ws1213/Artikel%20Diagnostische%20Studien%20WS%202012_13.pdf

Raul de la
Fuente-Fernandez, MD

ABSTRACT

Objective: To assess the role of DaTSCAN in the diagnosis of Parkinson disease (PD).
Methods: Using the sensitivity and specificity values obtained in the 2 studies that recently led

Correspondence & reprint

requests to Dr. de la
Fuente-Fernandez:
rfuente@medynet.com

the US Food and Drug Administration to approve the use of DaTSCAN for the diagnosis of PD,
calculations were carried out to estimate the accuracy of the clinical diagnosis taking DaTSCAN
findings as the standard of truth.

Results: In early PD, a clinical diagnosis of possible or probable PD has a sensitivity of 98% and
a specificity of 67%. The specificity increases to 94% once the clinical diagnosis becomes established. The overall accuracy of the clinical diagnosis is 84% in early PD and 98% at later stages.
The clinical diagnostic accuracy is mathematically identical to the diagnostic accuracy of
DaTSCAN imaging.
Conclusions: In the absence of neuropathologic validation, the overall accuracy of a clinical diagnosis of PD is very high and mathematically identical to the accuracy of DaTSCAN imaging, which
calls into question the use of radiotracer neuroimaging as a diagnostic tool in clinical practice.
Neurology 2012;78:696701
GLOSSARY
CI confidence interval; DAT dopamine transporter; FDA Food and Drug Administration; PD Parkinson disease;
SWEDD scans without evidence of dopaminergic deficit.

Parkinson disease (PD) is characterized by the progressive loss of dopaminergic neurons in the
substantia nigra pars compacta, leading to striatal dopamine depletion.1 As the clinical diagnosis of PD is not perfect,2,3 particularly in the early stages of the disease, an increasing number of
clinicians are using radiotracer neuroimaging as a diagnostic tool. Dopamine transporter (DAT)
SPECT, a less expensive and more widely available technique than PET, has already been incorporated into clinical practice in many European centers. Paradoxically, however, adequate neuropathologic validation of PD diagnosis based on DAT SPECT findings is still lacking.4,5
It should be noted that PD is a relatively common degenerative disorder that affects some
1%2% of the general population.6 Hence, a large-scale use of DAT SPECT as a diagnostic
tool in PD may potentially have substantial implications in terms of patients safety and management. According to a press release issued by General Electric Healthcare on April 13, 2011, DAT
SPECT has already been used in nearly 300,000 patients in Europe.7 In the United States, where
50,000 60,000 new cases of PD are diagnosed each year,8 the Food and Drug Administration
(FDA) has recently approved the use of DAT SPECT (DaTSCAN) for PD diagnosis.9
The objective of the present analysis was to examine the practical value of DaTSCAN
imaging and clinical diagnosis in PD. Sensitivity, specificity, diagnostic accuracy, and predictive values were calculated under 2 different scenarios.
METHODS In January 2011, the US FDA approved the use of DaTSCAN for the diagnosis of PD.9 This decision was based on 2
multicenter, phase III studies. Chronologically, the first study (Study DP008 003)10 was designed to determine the sensitivity and
specificity of DaTSCAN images in differentiating between patients with a established diagnosis of a parkinsonian syndrome (PD,
multiple system atrophy, and progressive supranuclear palsy) and subjects without parkinsonism (patients with essential tremor and
Editorial, page 688
From the Section of Neurology, Hospital A. Marcide, Ferrol, Spain.
Disclosure: Author disclosures are provided at the end of the article.
696

Copyright 2012 by AAN Enterprises, Inc.

Figure

Flow chart for DaTSCAN imaging (index test) and clinical diagnosis (reference test) in Parkinson
disease (parkinsonian syndrome [PS]) diagnosis (Study DP008003 Study PDT304)

healthy volunteers). Images were evaluated by on-site personnel

and also by a blinded image evaluation panel consisting of 5
investigators. The primary endpoint was the blinded on-site visual assessment of DaTSCAN images as normal or abnormal.
The standard of truth for judging the accuracy of the DaTSCAN
image assessments was the expert clinical diagnosis of the patient
made at baseline. Subjects with a parkinsonian syndrome were
presumed positive for a striatal dopaminergic deficit, and subjects with essential tremor and healthy volunteers were presumed
negative for a striatal dopaminergic deficit.
The second study (Study PDT304)11a prospective, longitudinal study had the same purpose as Study DP008 003,
but the study population consisted of patients with an early parkinsonian syndrome with or without tremor (possible and
probable PD) vs a combination of patients with non-PD
tremor (essential or dystonic tremor) and healthy volunteers.
Clinical and DaTSCAN assessments were made at baseline, 18,
and 36 months of follow-up. The primary endpoint was the
baseline DaTSCAN image assessment by 3 independent blinded
readers as normal or abnormal. The standard of truth was the
clinical diagnosis established by 2 independent movement disorder specialists in consensus, based on the assessment of patients
clinical examination videos at 36 months of follow-up. The standard of truth was used to judge whether or not a subject had a
striatal dopaminergic deficit. Further methodologic details for
the 2 studies can be found elsewhere.5,10,11
As there is no proper neuropathologic validation of
DaTSCAN PD diagnosis, calculations were performed under 2
hypothetical scenarios: 1) assuming that the standard of truth is
the clinical diagnosis (i.e., following the original design of Study
DP008 003 and Study PDT304); and 2) assuming that the
standard of truth is the diagnosis derived from DaTSCAN findings. Sensitivity, specificity, diagnostic accuracy, and positive
and negative predictive values, as well as the corresponding 95%

confidence intervals (CI), were calculated following recommended methodology.12

RESULTS Study DP008 003 was conducted between August 1997 and February 1998 in 6 European sites (2 in Germany, 2 in the United Kingdom,
and 1 each in the Netherlands and Belgium), and
included a total of 248 participants. The vast majority of patients with parkinsonism (82%) were diagnosed clinically as PD.10 Study PDT304, which
included a total of 202 participants, was conducted
between January 1999 and June 2005 in 10 European sites (4 in the United Kingdom, 2 in Spain, and
1 each in Austria, Belgium, Germany, and Portugal).11 In Study PDT304, patients with possible or
probable parkinsonism were assumed to have PD,
although a small proportion could have other degenerative parkinsonism. The figure shows a flow chart
of the 2 studies. Demographics and clinical characteristics of participants in both studies, as well as a
detailed account of adverse events and missing data
management, are provided elsewhere.5,10,11 The interreader agreement with regard to the visual assessment
of DaTSCAN images was very high in both studies
(Cohen kappa values ranged from 0.83 to 1).5,11
Tables 1 4 give calculation details for sensitivity,
specificity, and predictive values. For Study
PDT304, reader A evaluated 102 scans, reader B
evaluated 99 scans, and reader C evaluated 101 scans;
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697

Table 1

Table 3

Study PDT304 (subjects with

early symptoms)a
Clinical
diagnosis ()

Clinical
diagnosis ()

DaTSCAN
()

DaTSCAN
()

Clinical
diagnosis ()

56

15

71

Clinical
diagnosis ()

30

31

57

45

102

Totals

DaTSCAN ()

56

57

DaTSCAN ()

15

30

45

Totals

71

31

102

Abbreviation: CI confidence interval.

a
Role of DaTSCAN in the diagnosis of Parkinson disease
(parkinsonian syndrome) assuming that the clinical diagnosis is the standard of truth. Sensitivity 56/71 0.79
(79%; 95% CI 68%, 87%); specificity 30/31 0.97
(97%; 95% CI 84%, 99%); positive predictive value 56/
57 0.98 (98%; 95% CI 91%, 100%); negative predictive
value 30/45 0.67 (67%; 95% CI 52%, 79%); overall
diagnostic accuracy (5630)/102 0.84 (84%; 95% CI
76%, 90%).

combined estimates of the 3 readers were used in the

calculations shown in tables 1 and 3.
Under scenario 1 (clinical diagnosis as the standard of truth), DaTSCAN sensitivity and specificity
values were 79% and 97% in Study PDT304, and
97% and 98% in Study DP008 003 (tables 1 and
2). The positive and negative predictive values were
98% and 67% in Study PDT304, and 99% and 94%
in Study DP008 003.
Under scenario 2 (DaTSCAN as the standard of
truth), Study PDT304 suggests that the clinical diagnosis in early PD has high sensitivity (98%) but relatively low specificity (67%) (table 3). In more
advanced stages (Study DP008 003), the sensitivity
remains virtually identical (99%) but the specificity
increases substantially (94%) (table 4). The estimated positive predictive value of the clinical diagnosis was 79% in early PD (Study PDT304), and 97%
once the clinical diagnosis becomes established
(Study DP008 003). The estimated negative predictive value of the clinical diagnosis was very high in

Totals

both cases (97% in Study PDT304 and 98% in

Study DP008 003).
Study PDT304 likely reflects the most common
situation in which clinicians may want to use
DaTSCAN imaging as a diagnostic tool to confirm
an early diagnosis of possible or probable PD.
Taking DaTSCAN findings as the only guide to treatment management, Study PDT304 suggests that the
use of DaTSCAN imaging could improve treatment
management, saving unnecessary medications in
15% (15/102) of the cases and identifying 1% (1/
102) of patients in need of specific treatment. Conversely, if the clinical diagnosis actually reflects the
patients true condition, therapeutic strategies based on
DaTSCAN findings would miss needed treatment in
15% (15/102) of patients with early PD and would unnecessarily treat 1% (1/102) of the cases.
As one can easily verify in the above results (see
also tables 1 4), there are several mathematical iden-

Study DP008003 (subjects with

established clinical diagnosis)a
Clinical
diagnosis ()

Clinical
diagnosis ()

DaTSCAN ()

154

155

DaTSCAN ()

61

65

158

62

220

Totals

Abbreviation: CI confidence interval.

a
Role of DaTSCAN in the diagnosis of Parkinson disease
(parkinsonian syndrome) assuming that the clinical diagnosis is the standard of truth. Sensitivity 154/158 0.97
(97%; 95% CI 94%, 99%); specificity 61/62 0.98
(98%; 95% CI 91%, 100%); positive predictive value
154/155 0.99 (99%; 95% CI 96%, 100%); negative
predictive value 61/65 0.94 (94%; 95% CI 85%,
98%); overall diagnostic accuracy (15461)/220
0.98 (98%; 95% CI 95%, 99%).
698

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March 6, 2012

Study DP008003 (subjects with

established clinical diagnosis)a
DaTSCAN
()

Totals

Totals

Abbreviation: CI confidence interval.

a
Role of clinical diagnosis in the diagnosis of Parkinson disease (parkinsonian syndrome) assuming that DaTSCAN is
the standard of truth. Sensitivity 56/57 0.98 (98%;
95% CI 91%, 100%); specificity 30/45 0.67 (67%;
95% CI 52%, 79%); positive predictive value 56/71
0.79 (79%; 95% CI 68%, 87%); negative predictive
value 30/31 0.97 (97%; 95% CI 84%, 99%); overall
diagnostic accuracy (5630)/102 0.84 (84%; 95% CI
76%, 90%).

Table 4
Table 2

Study PDT304 (subjects with

early symptoms)a

DaTSCAN
()

Totals

Clinical
diagnosis ()

154

158

Clinical
diagnosis ()

61

62

155

65

220

Totals

Abbreviation: CI confidence interval.

a
Role of clinical diagnosis in the diagnosis of Parkinson disease (parkinsonian syndrome) assuming that DaTSCAN is
the standard of truth. Sensitivity 154/155 0.99 (99%;
95% CI 96%, 100%); specificity 61/65 0.94 (94%;
95% CI 85%, 98%); positive predictive value 154/
158 0.97 (97%; 95% CI 94%, 99%); negative predictive
value 61/62 0.98 (98%; 95% CI 91%, 100%); overall
diagnostic accuracy (15461)/220 0.98 (98%; 95%
CI 95%, 99%).

tities: 1) the sensitivity and specificity under scenario

1 correspond to the positive and negative predictive
values under scenario 2; 2) the positive and negative
predictive values under scenario 1 correspond to the
sensitivity and specificity under scenario 2; and,
more importantly, 3) the overall diagnostic accuracy
of DaTSCAN imaging under scenario 1 corresponds
to the clinical diagnostic accuracy under scenario 2
(84% in early PD, and 98% at later disease stages).
DISCUSSION The comprehensive analyses presented here only intend to show that very similar
sensitivity, specificity, and predictive values as those reported for DaTSCAN imaging in predicting striatal dopaminergic deficit can be obtained for the clinical
diagnosis. Most importantly, this study emphasizes the
need for proper neuropathologic validation. Until then,
we are only evaluating (in a rather convoluted and expensive manner) the ability of DaTSCAN imaging to
predict the clinical diagnosis or, conversely, the ability
of the clinical diagnosis to predict DaTSCAN image
findings. Naturally, the same arguments apply to other
radiotracer neuroimaging techniques.
There is only one study (the Walker Study) that
could potentially shed some light on the ability of
DaTSCAN imaging to predict striatal dopaminergic
deficit.4 It is a prospective clinicopathologic study
designed to assess the accuracy of DaTSCAN imaging using the neuropathologic diagnosis at autopsy as
the standard of truth. Currently, autopsy results are
available from 27 subjects: 14 patients with dementia
with Lewy bodies, 4 patients with PD, 7 patients
with Alzheimer disease, 1 patient with corticobasal
degeneration, and 1 healthy control subject.5 On this
population, the sensitivity and specificity of
DaTSCAN image assessments were 85% and 86%,
respectively.5 While admittedly not totally comparable to the Walker Study, clinicopathologic observations in PD suggest that the sensitivity and specificity
of a clinical diagnosis (as established at 2 years of
symptom onset) can be as high as 91% and 98%,
respectively3; taking into account previous clinicopathologic studies,2,3 the most likely estimate of the
overall clinical diagnostic accuracy is 90%.
With the data currently available, we can only
speculate on hypothetical scenarios. The overall accuracy of the clinical diagnosis taking DaTSCAN as
the standard of truth is mathematically identical
to the overall diagnostic accuracy of DaTSCAN taking
the clinical diagnosis as the standard of truth. The
sensitivity, specificity, and predictive values obtained
in the PDT304 and DP008 003 studies, which are
similar to those found in other studies,13-14 suggest
that the overall accuracy of a clinical diagnosis of PD
is very high (84% in early PD; 98% once the clinical

diagnosis becomes established). Hence, the information provided by DaTSCAN imaging is redundant
in at least 84% of the cases. In other words, even
assuming that DaTSCAN findings indeed reflect the
patients true condition, the vast majority of scans
would be unnecessary from a diagnostic standpoint.
These estimates oblige to question the current tendency to use of DaTSCAN on a large-scale basis in
clinical practice, raising also concerns in relation to
patients safety and management. At least 250,000 of
the 300,000 patients scanned in Europe since 2000
may have been unnecessarily exposed to iodine-123
gamma radiation. It is known that the risk of developing cancer from radiation exposure depends on
several factors, including the radiation dose, the cumulative effective dose, and the age at exposure.15-17
Approximate cancer risk estimates can be obtained
by comparing procedures with similar effective
doses.15 Although the effective dose of DaTSCAN
imaging is relatively low (3.94 mSv) and the target
population is typically old, a potential increase in the
risk of cancer remains a serious consideration when
dealing with large populations. A recent study suggests that 1 in 5,000 patients who underwent a routine CT of the neck (4 mSv) at age 40 years will
develop cancer from that CT scan; if the scan was
done at age 60 years, the corresponding cancer risk
estimate was 1 in 7,500.17 Some authors argue that a
second DaTSCAN at 2-year follow-up could reduce
diagnostic uncertainty in PD.14 Unfortunately, doubling the dose of radiation (8 mSv in 2 years) increases substantially the risk of cancer. It has been
estimated that 1 in 1,500 patients who underwent a
routine CT of the chest (8 mSv) at age 60 years will
develop cancer from that CT scan.17 Naturally, neck
and chest CT scans can lead to life-saving treatments
and have therefore a very favorable risk to benefit ratio
compared to DaTSCAN imaging for PD diagnosis.
The use of DaTSCAN in clinical practice also has
implications in terms of patients management. Assuming that DaTSCAN findings reflect the patients
true condition, it would be reasonable to argue that
imaging results should guide therapy. This strategy
could potentially save some 15% of early patients
from receiving unnecessary medications (subjects
with scans without evidence of dopaminergic deficit [SWEDDs]). Some (perhaps most) of these
SWEDDs may indeed have a medical condition different from PD, the nature of which is not yet
clear.18,19 However, if the patients true condition is
best estimated by the clinical diagnosis, then the
same 15% of early patients may miss a much needed
treatment. For example, parkinsonian patients with
dopa-responsive dystonia, who characteristically have
normal DAT binding findings, greatly benefit from
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699

levodopa therapy.20,21 Preliminary data suggest that

DaTSCAN imaging leads to more changes in diagnosis
and management, increasing also clinicians confidence
in the diagnosis.22 Still, this does not seem to result in
better quality of life for the patient.22
In terms of differential diagnoses, DaTSCAN imaging cannot reliably distinguish between PD and
other degenerative parkinsonisms, such as multiple
system atrophy or progressive supranuclear palsy,
whenever evaluated on a case-by-case basis. This important point is specifically recognized in the FDA
briefing document.5 The analyses presented here suggest that a distinction between PD and non-PD
tremor is not always straightforward, and the same
applies to PD vs vascular parkinsonism, especially in
the elderly.13 One could reasonably argue that
DaTSCAN imaging should be most helpful to confirm a clinical diagnosis of psychogenic or druginduced parkinsonism. However, contrary to what
one would expect, several studies have encountered
abnormal DaTSCAN findings in a surprisingly high
number of patients clinically diagnosed as having
psychogenic23 or drug-induced parkinsonism.24 It remains unknown whether these imaging changes are
functional or structural in nature. Psychologically or
drug-induced downregulation of DAT expression is
certainly a possibility. In support of this notion,
DaTSCAN abnormalities in subjects with schizophrenia treated with neuroleptics are unrelated to
neuroleptic-induced parkinsonism.25 In other words,
DaTSCAN imaging does not predict whether a given
neuroleptic-treated patient will develop parkinsonism or not. Despite all these limitations, functional
neuroimaging might be helpful in carefully selected
cases, particularly in patients without a clear clinical
diagnosis in which an invasive procedure (e.g., deep
brain stimulation) is contemplated as a treatment option. Nonetheless, in clinical practice, the reliability
of DaTSCAN imaging is far from optimal. A 2-year
longitudinal study found discrepancies between the
first and second readings in nearly 50% of the cases
with repeated DaTSCAN.14 Inexplicably, these discordant results were mostly due to cases with abnormal images in the first scan and normal images in the
second scan, performed 2 years later.14
Neuropathologic studies are definitely needed to
assess the diagnostic accuracy of radiotracer neuroimaging compared to the clinical diagnosis. Until these
assessments are available, it may be premature to embark on a large-scale use of DaTSCAN imaging for
the diagnosis of PD.
DISCLOSURE
Dr. de la Fuente-Fernandez serves on the editorial board of Parkinsonism
and Related Disorders.
700

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Received May 23, 2011. Accepted in final form August 3, 2011.

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