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parison between [18F]uciclovine and PSMA in
50 patients with post-radical prostatectomy biochemical recurrence and PSA levels <2ng/mL
has shown that PET-CT with labeled PSMA has
detection rates for pelvic lymph node regions and
for extra-pelvic metastasis meaningfully greater
than [18F]uciclovine [32]. The results of a similar study published in the same year underline the
advantage of [18F]uciclovine in detecting curable localized disease in close anatomical relation to the urinary bladder, whereas [68Ga]
PSMA-11 fails because of tracer’s physiological
accumulation, while detection rates in assessing
distant metastases in recurrent PCa are almost
equivalent to [68Ga]PSMA-11 [29].
Generally, PET-CT’s sensitivity in identifying
disease relapses is higher in patients with higher
blood levels of PSA, while PSA kinetics does not
seem to be predictor of a positive scan [33, 34].
Although the impact of PSA levels on [18F]uciclovine PET-CT positivity rate is known, literature
data are conicting on which PSA threshold can
reliably identify the presence of early disease recurrence [35]. Different PSA levels, ranging from 0.3
to 1ng/mL, have been suggested as reliable threshold for a positive scan [35, 36]. The results of more
recently published studies, in which cohorts of
patients with very low PSA values (≤1 ng/mL)
were enrolled, have shown that [18]uciclovine is
able to maintain a signicant overall detection rate
even for very low PSA values [37, 38].
With regard to the biological behavior of the
disease, a higher detection rate of [
18
F]uciclovine has been documented in the most aggressive
forms of prostate cancer, [39, 40], in particular in
patients with Gleason score (GS)≥8, stages T3–
T4, and castration-resistant disease [41].
The interval time from primary treatment to
PSA relapse (TTR) is the only clinical parameter
related to tumor aggression for which a signicant inverse correlation with the detection rate
has been demonstrated, with an optimal cut-off
of 20months [34].
Regarding the sensitivity of the method based
on the recently validated EAU BCR risk groups,
Selnæs etal. described a lower detection rate of
[18F]uciclovine PET-MR in the UAE low-risk
BCR group, without however reaching statistical
signicance due to the small sample size exam-
42]; therefore, further studies are needed.
ined [
Finally, the localization of disease recurrence
on [18F]uciclovine PET-CT may be inuenced
by the type of primary curative treatment; among
the patients enrolled in the FALCON trial, the
detection rate was signicantly lower in patients
undergoing prostatectomy (32%) than in those
with intact prostate (95%) [43].
Finally, androgen deprivation therapy (ADT)
does not seem to have a negative impact on the
positivity rate of [18F]uciclovine PET-CT [44].
In order to correctly characterize the recurrence of prostate cancer, it is important to dene
whether the disease is conned to the prostate or
the prostate bed or has an extraprostatic
development.
In patients with an intact prostate, [18F]uciclovine PET-CT has a high sensitivity (88–90%)
against a low specicity (32–40%) in identifying
local disease recurrence [2, 45]; this low specicity is probably due in part to submaximal local
therapy with residual viable prostate tissue characterized by non-specic uptake. Consequently,
in patients with an intact prostate gland, a local
uptake of [18F]uciclovine requires histological
conrmation.
[18F]Fluciclovine has high specicity and
medium/high sensitivity on the basis of PSA levels in identifying lymph node recurrence.
Overall sensitivity, specicity, and accuracy
of [18F]uciclovine in the detection of extraprostatic disease are 55%, 97%, and 73%, respectively [
45]; in a large multicenter study with 596
enrolled patients, a high positive predictive value
(PPV) of 92.3% in the detection of extraprostatic
disease has been described [2].
Regarding skeletal recurrence, metastatic
bone lesions can be detected on [18F]uciclovine
PET-CT before the appearance of morphostructural changes on CT.
[18F]Fluciclovine has shown to accumulate in
osteolytic and osteosclerotic lesions with high
cell density [46]; this tracer typically shows
intense focal uptake in lytic bone lesions and
variable activity in sclerotic lesions. It has been
hypothesized that sclerotic lesions can be characterized by a low number of tumor cells, with a
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consequent lower uptake, difcult to distinguish
from the physiological bone marrow activity.
Since dense sclerotic lesions may be characterized by little or no [18F]uciclovine uptake, it
is therefore advisable to perform in these cases an
additional skeletal-specic imaging [47].
Unfortunately, in most of the early clinical
studies carried out, the presence of a positive
bone scan represented an exclusion criteria;
therefore, in the absence of further evidence,
[18F]uciclovine PET-CT is currently not recommended as a substitute for bone scan or PET-CT
with [18F]NaF.
Rescue radiotherapy (RT) of the prostate or
prostate bed and pelvis is commonly performed
in patients with biochemical recurrence [45, 48].
Conventional CT and MRI imaging is routinely
used for the denition of the target clinical volume. Despite consensus guidelines for target volume denition published by the Radiation
Therapy Oncology Group (RTOG) [49], disease
diffusion may be underestimated, resulting in
failure of the biochemical response.
Thanks to the introduction of functional imaging such as [18F]uciclovine PET-CT, more
patients present a suspect extraprostatic disease
[30]; additional information provided from [18F]
uciclovine PET-CT scan may therefore inuence radiation treatment planning.
A recent study reported a signicant change in
radiotherapy planning in 40.5% of patients with
biochemical failure randomized to undergo [18F]
uciclovine PET-CT in addition to standard-ofcare imaging before radiotherapy [50] and
described a signicant change in the denition of
the target volume when [18F]uciclovine PET-CT
results were included in the treatment planning; a
signicant change in radiotherapy treatment
planning was also reported by the pivotal
LOCATE study [30].
Finally, several studies show that [18F]uciclovine PET-CT may also play a role in the staging of primary prostate cancer [51, 52]; although
the data are very promising, the currently available radiopharmaceuticals, including [18F]uciclovine, have yet to show acceptable sensitivity
values to be considered for routine clinical use in
the primary staging phase [53, 54].
14.4.2 PET-MRI
Despite its proven usefulness, PET-CT has some
limitations, especially with regard to the local
staging of prostate cancer and the characterization of some incidental lesions: in these situations, further evaluation by magnetic resonance
imaging (MRI) may be indicated, in order to
allow an optimal clinical management. The high
MRI contrast soft-tissue and its ability to determine cell density through diffusion-weighted
images (DWI) represent a powerful supplement
to the metabolic information derived from
PET. Consequently, the recent introduction in
clinical practice of hybrid PET-MRI imaging
offers the potential advantage of improving the
diagnosis, initial staging, and restaging of numerous types of cancer.
Several recent studies have shown that hybrid
PET-MRI imaging can improve diagnostic accuracy in prostate cancer compared to other imaging modalities, allowing to make a better patient
selection for rescue therapies and to guide personalized treatment.
There are many advantages deriving from the
use of PET-MRI imaging: in general compared to
the sequential use of multiparametric MRI and
PET-CT, hybrid PET-MRI imaging allows to
reduce scan times, offers a better logistical solution for patients, and allows to reduce patient
radiation exposure, as CT scanning is not
required.
Since [
only by neoplastic tissue but also by normal prostate tissue and other prostatic pathologies (such
as benign prostatic hyperplasia and prostatitis),
the integration of information deriving from T2
weighted (T2W) and diffusion weighted (DW)
MRI sequences with those deriving from PET
allows to more easily discriminate malignant
from benign tissue and to improve the detection
and characterization of prostate cancer in selected
cases [55].
Regarding the assessment of lymph node
recurrence, MRI sensitivity and specicity may
be limited by size and nodal morphology [56,
57]; it is well known that normal-appearing
lymph nodes on CT and MRI can harbor meta-
18
F]uciclovine can be adsorbed not
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static disease [58–62]: given that [18F]uciclovine has shown high accuracy in detecting nodal
and distant metastases in recurrent prostate
cancer, the integrated use of the two methods can
improve this potential limitation of MRI.
Most of the published studies concern the use
of combined PET-MRI imaging in the staging of
primary prostate cancer; Turkbey et al. showed
that combining the information from [18F]uci-
clovine PET with multiparametric MRI (mpMRI)
increased the positive predictive value for detecting prostate cancer from 76% for mpMRI alone
to 82% [53].
Elschot etal. found that PET-MRI discriminated better than MRI or PET alone between
tumor and benign tissue and between high-grade
tumor and other tissue (including low-grade
tumor) [56].
Similarly Galgano etal. showed that [18F]uciclovine PET-MRI has a potential role in initial
staging of high-risk prostate cancer and in evaluating response to ADT [63]. Regarding lymph
nodes staging, Selnæs et al. described high
specicity but low sensitivity of [18F]uciclovine PET- MRI for the detection of lymph node
metastases in high-risk prostate cancer patients
[64].
Regarding the performance of [18F]uciclovine PET-MRI in the evaluation of osseous
metastases from castration-resistant prostate cancer, the study by Amorim etal. suggests that [18F]
uciclovine does not confer a signicant increase
in sensitivity over MRI alone, especially in case
of densely sclerotic lesions [
42, 65].
Finally, with regard to the use of PET-MRI in
restaging phase in case of biochemical disease
recurrence, it has been shown that PET-MRI
may be useful to select patients for appropriate
treatment, but it is of limited use at low PSA
values or in patients classied as UAE LowRisk BCR.
However, the studies performed have several
limitations, mainly represented by the small sample size analyzed; therefore, new studies with
larger patients cohorts are needed in order to
dene the correct diagnostic value of [18F]uciclovine PET-MRI imaging and to justify its routinary clinical use.
14.4.3 Other Malignancies
Although the use of [18F]uciclovine is currently reserved for patients affected by recurrent
prostate cancer, it was initially developed for
PET imaging of brain tumors [1] and has also
allowed in several cases to identify other neoplasms [66].
It is not rare to nd a second primary neoplasm on a [18F]Fluciclovine PET-CT performed
for prostate cancer evaluation, and colorectal
cancer represent the most common of the occasionally detected primary cancers [67].
Regarding the study of brain neoplasms,
PET-CT with marked amino acids has proven to
be very useful in integrating MRI in the diagnostic imaging of gliomas; amino acid tracers typically have a high uptake in tumor cells and a low
concentration in normal brain tissue [68–72].
[18F]Fluciclovine PET-CT may therefore play a
role in the imaging of brain tumors; following
results from a recent review have been reported:
glioma and glioblastoma are FACBC-avid
tumors, with a detection rate of about 100%; [18F]
uciclovine PET-CT has a high diagnostic accuracy, higher than MRI in dening tumor extension, volumes, and in characterizing satellite
lesions; compared to methionine, it has similar
diagnostic accuracy but a better tumor-tobackground ratio; nally, [18F]uciclovine seems
able to help in discriminating between low- and
high- grade gliomas [73].
These data derive from small patient samples;
consequently, in order to clarify the real clinical
and diagnostic role of [
18
F]uciclovine in this setting and its possible position in the diagnostic
owchart, further studies with larger cohorts of
patients are needed.
14.5 PET/CT Acquisition Protocols
14.5.1 Patient Preparation
Since muscle uptake of [18F]uciclovine can be
inuenced by physical activity linked to an
increase in the rate of protein synthesis and degradation and amino acid transport, it is generally
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recommended to patients to avoid strenuous
exercise for at least 1day before the exam.
Fasting for at least 4h is generally required
before scanning, but oral hydration with water to
take medications and to avoid oral dryness is
allowed.
Patients should hold their urine for at least
30–60min prior to injection, unless this prevents
them from standing still or completing imaging.
At the end of the examination, oral hydration
and frequent diuresis must be recommended during the rst hours after the scan, in order to reduce
the radiation exposure of the bladder.
14.5.2 Recommendations for[18F]
Fluciclovine Infusion
andAdministered Tracer
Activity
[18F]Fluciclovine should be administered as a
bolus intravenous injection; the maximum recommended injection volume of the undiluted
product is 5mL; however, it can be diluted with a
9mg/mL (0.9%) sodium chloride solution by a
factor of 8 (1+7 dilution). The injection should
be followed by intravenous ushing of a sterile
9 mg/mL (0.9%) sodium chloride solution to
maximize use of the dispensed activity. The recommended injected activity is 370 MBq
(10mCi). No weight based dosage adjustment is
recommended as an analysis of the potential
impact of body mass changes did not demonstrate any substantial change in effective radiation dose. Furthermore, no dosage adjustment is
required for the elderly population.
14.5.3 [18F]Fluciclovine PET/CT
Acquisition Protocol
andReconstruction
On the basis of the pharmacokinetic characteristics described above, the radiopharmaceutical
injection should be performed with the patient
already positioned supine on the tomograph
table, in order to start the scan 3–5 min after
administration.
Once the patient is positioned comfortably,
the CT scan can be started, followed by the PET
scan, 3–5min after the injection.
It is also possible, before starting the standard
scan, to perform an initial dynamic scan (0–5min)
of the pelvic region.
The standard scan should start at the pelvic
region and end at the base of the skull. For clinical reasons, the scan can be extended to the cranial vertex. If for clinical reasons it is required to
extend the image acquisition to the lower limbs,
it is advisable to perform it as a separate acquisition immediately after the initial imaging, keeping the arms along the body for comfort.
Assuming that the small lesions observed on
PET can be better characterized by a diagnostic
quality CT, the acquisition parameters of the CT
and PET will in any case depend on the characteristics of the scanner provided in the various
centers.
The use of CT contrast is optional but appears
to have a limited impact on the quality of the
imaging and interpretation of the study; it is also
possible that iodinated contrast diuresis may
stimulate early urinary excretion of the
radiotracer.
Time-of-ight (TOF) PET with a reconstruction method including modeling of resolution
degradation, often referred to as point spread
function (PSF) reconstruction, may help with the
detection of small lesions.
A CT bone reconstruction algorithm is recommended in addition to the standard CT
reconstruction.
The study of the images must be carried out
after fusion of the PET data with the standard and
bone CT reconstructions.
PET-MRI can be used as an alternative or supplement to PET-CT in prostate cancer.
Details of the acquisition protocol and reconstruction for PET-MRI are beyond the scope of
this guideline.
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14.6 Interpretative Criteria
Generally soft-tissue lesions with a maximum
diameter>1cm can be dened as suspicious for
disease recurrence if the degree of uptake is
higher to that of the bone marrow, preferably
measured at the level of the L3 vertebrae.
Conversely, lesions with a maximum diameter<1cm may be subject to partial volume effect,
but if localized in the typical sites of metastases,
they should be interpreted as suspicious if the
degree of uptake is equal to or similar to that of
the bone marrow and greater than that measured
on the blood pool of the abdominal aorta.
As for the study of the prostate bed in patients
who have undergone surgery (prostatectomy with
or without seminal vesicles removal), focal
uptake (SUVmax) ndings equal to or greater
than the bone marrow (SUVmean) are to be considered suspected for malignancy, while ndings
with uptake values between bone marrow and
blood pool do not meet malignancy criteria, but
should be reported as requiring close follow-up
and/or correlation with MRI.
A symmetrical radio-concentration on seminal vesicles similar to that of the blood pool is
probably physiological, both in patients who
have undergone prostatectomy and radiotherapy,
while an asymmetric uptake between blood pool
and bone marrow may represent malignancy,
requiring MRI correlation.
On patients who have undergone radiotherapy,
brachytherapy, cryotherapy, HiFU (highfocused ultrasound), suspicious ndings may be
characterized by diffuse, focal, or multi-focal
uptake, in any case higher than the average bone
marrow activity, while ndings with uptake
between that of the blood pool and the bone marrow are worthy of close follow-up or MRI
correlation.
Lymph nodes with maximum diameter≥1cm
located in the typical areas of prostate cancer
recurrence characterized by an uptake equal to or
greater than the bone marrow should be considered suspected for malignancy; a degree of uptake
between the blood pool and the bone marrow
activity does not meet the criteria of malignancy
but should be reported as requiring close follow-
intensity
up; if uptake is less than or equal to the blood
pool, the lymph node can be considered as
benign.
Uptake equal to or greater than the blood pool
but signicantly lower than the bone marrow
does not meet the positivity criteria, but should
still be reported as requiring close monitoring.
High uptake ndings in lymph nodes located
in atypical sites for recurrence (for example,
inguinal, external iliac, hilar, and axillary regions)
should be considered suspect for recurrence only
if present in a context of other malignant diseases; otherwise, moderate symmetrical uptake
can be interpreted as physiological.
Lymph nodes located in the distal external
iliac stations can be considered pathological if
the uptake is isolated and asymmetrical and if the
causes of false positivity such as the presence of
neighboring vascular grafts or orthopedic devices
can be excluded.
Necrotic lymph nodes can cause false negative
results.
The presence of focal skeletal uptake to “maximum intensity projection” (MIP) PET images
should be considered suspicious for malignancy.
Lytic lesions tend to have higher uptake levels
than sclerotic lesions.
The presence of suspicious bone abnormality
on CT such as sclerosis without uptake can represent causes of false negativity; in these cases, further diagnostic investigations with other imaging
modalities (MRI, Na[18F]F PET-CT, conventional
bone scan SPECT-CT, or PSMA if approved for
use) should be recommended.
[18F]Fluciclovine is characterized by a higher
heterogeneity of bone marrow activity than [
18
F]
FDG and careful PET windowing is helpful.
High uptake may be present following a traumatic event (such as compression fractures).
Finally, areas of normal bone marrow regeneration (characteristic sites are pelvis and proximal femoral regions) may show increased
physiological uptake; in these cases, it is advisable to perform an integrated MRI study, especially in the absence of clear CT correlates and if
the ndings are solitary.
With regard to the liver, areas characterized by
focal uptake higher than the activity of the healthy
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liver should be considered suspicious for
malignancy.
Areas characterized by activity lower than the
healthy liver, but higher than the medullary one,
may also represent localizations of disease and
are therefore worthy of diagnostic integration
with morphological imaging.
14.7 Variants andPitfalls
[18F]Fluciclovine PET-CT image evaluation can
be misled by the presence of false positive (FP)
and false negative (FN) results [19, 74].
In the prostate gland, potential false positive
results include benign prostatic hyperplasia,
inammation, and post-actinic brosis [75].
False positive results at the lymph node level
can be caused by inammation or acute and
chronic infections, especially if symmetrical and
in atypical sites of prostate cancer.
Occasionally, a cause of false positivity may
be a high uptake at the level of the middle lobe
(central invagination of the base of the prostate
inside the bladder), caused by the presence of
prostatic hypertrophy in this region.
Finally, it should be noted that anecdotally,
median lobe uptake (central base invaginating
into the bladder) has a higher false positivity due
to an increased presence of prostatic hypertrophy
in this region.
A certain degree of uciclovine uptake has
also been observed on inammatory skin lesions,
inguinal lymphadenopathy caused by ringworm
infection and musculoskeletal inammation.
[18F]Fluciclovine uptake in renal masses
should be further investigated, as could represent
a malignant etiology. Papillary renal cell carcinoma has been shown to have a higher uptake,
while clear cell carcinoma has an uptake equal to
the renal parenchyma [76].
Benign bone lesions such as osteoid osteoma
may have moderate uptake.
Mild radio-concentration may also be
observed in degenerative disc and facet disease,
although less common and less intense than is
normally observed with [18F]FDG.
Occasionally, intense benign/non-specic
activity may be observed at the level of the joints
or at the muscle insertions.
Benign meningioma can have intense uptake
[77].
Pituitary and adrenal adenomas may eventually be characterized by a greater focal uptake of
the surrounding tissue.
Finally, as reported above, possible false negative results can be observed in presence of
necrotic metastatic lymph nodes and some types
of sclerotic bone lesions. In the following, we
present a case series illustrating some applications of [18F]Fluciclovine in various clinical settings (Figs.14.3, 14.4, 14.5, 14.6, and 14.7).
Fig. 14.4 Patient previously submitted to radiotherapy
due to prostatic carcinoma (Gleason score 3+3), subsequently submitted to hormone therapy with LHRH.Due
to progressive PSA increase (pre PET-CT scan value of
2.73ng/mL, DT< 10 months), a restaging [
vine PET-CT has been scheduled. [
imaging (a) revealed some areas of focal uptake in the
18
18
F]Fluciclovine MIP
F]uciclo-
pelvis (black arrows); PET (b, e), and especially fused
PET/CT transaxial slices (d, g) revealed focal uptake of
the tracer in the right iliac lymph nodes (white arrows).
The patient was then submitted to stereotactic RT with
complete metabolic response. Images c and f show coregistration CT transaxial slices used for fusion
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ab
c
d
Fig. 14.3 Patient previously submitted to surgery (prostatectomy and vesiculectomy) due to prostatic carcinoma
(Gleason score 7, pT3a), subsequently submitted to hormone therapy with LHRH.Due to a recent cystoscopic
nding of disease recurrence in the posterior wall of the
bladder, a restaging [
18
F]Fluciclovine MIP imaging (a) revealed some
uled. [
18
F]uciclovine PET-CT was sched-
areas of focal uptake in the pelvis (black arrows); PET (b,
e) and especially fused PET/CT transaxial slices (d, g)
revealed focal uptake of the tracer in the posterior-inferior
wall of the bladder (white short arrow) and in the right
iliac nodes (white long arrow). Images c and f show coregistration CT transaxial slices used for fusion
e
f
g
a
b
c
d
e
f
g
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ab
c
d
Fig. 14.5 Patient previously submitted to surgery (prostatectomy) due to prostatic carcinoma (Gleason score 8,
pT3b, pN0), stereotactic radiotherapy in the prostatic bed
and hormone therapy with LHRH. Due to progressive
PSA increase (pre PET-CT scan value of 4 ng/mL,
DT<6 months), a [
18
F]Fluciclovine MIP imaging (a) revealed some
uled. [
18
F]uciclovine PET-CT was sched-
areas of focal uptake in the pelvis (black arrows); PET (b,
e) and fused PET/CT transaxial slices (d, g) revealed focal
uptake of the tracer in the right sacral bone (white short
arrow) and in the left ilium (white long arrow), while coregistration CT transaxial images (c, f) did not show clear
osteostructural modications
e
f
g
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ab
c
d
Fig. 14.6 Patient previously submitted to surgery (prostatectomy) due to prostatic carcinoma (Gleason score 8,
pT3a, pN0, R1). After 2years, a progressive increased
PSA value was registered and a [
was scheduled. PSA before PET/CT execution was
5.73ng/mL. [
an area of intense focal uptake in the pelvis (black short
arrow) and mild focal concentration in the left upper thigh
region (black long arrow). PET (b) and fused PET/CT
18
F]Fluciclovine MIP imaging (a) revealed
18
F]uciclovine PET-CT
transaxial slices (d) revealed focal uptake of the tracer in
a centimetric lymph node along the left external iliac
chain (white short arrow), while PET (e) and fused PET/
CT transaxial slices (g) showed focal mild uptake in the
internal trabecular portion of proximal epiphyseal region
of the left femur (white long arrow), attribute to physio-
18
logical [
marrow reconversation. Images c and f show co-registration CT transaxial slices used for fusion
F]uciclovine incorporation in an island of bone
e
f
g
ab
Fig. 14.7 A 71-year-old patient, previously submitted to
radical prostatectomy due to prostate cancer (GS 8, pT3a).
After 3years, a progressive increased PSA value was registered. PSA before [
0.38ng/mL (DT<6months). [
(a–d) resulted negative. The same patient examined
cf
d
18
F]choline PET/CT execution was
18
F]choline PET/CT scan
e
h
g
2months later with PET/CT with [
imaging detected increased tracer incorporation in a small
sub-centimetric iliac node (e, black arrow; f and g, white
arrow). The patient was then submitted to stereotactic RT
with complete metabolic response
18
F]Fluciclovine (e–h):
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14.8 Clinical Cases
See Figs.14.3, 14.4, 14.5, 14.6, and 14.7.
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