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6 Radiation Safety and Dosimetry
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107
(ICRP) for the determination of effective dose is
0.01 for skin compared to 0.05 for breast according to ICRP60 [4] or 0.12 according to ICRP103
[1]. Hence, in patients with melanoma, the local
radiation dose contributes little to the effective
dose. In melanoma patients, the radiolabeled colloid migrates minimally throughout the bloodstream or reticuloendothelial system (RES) or
beyond the SLN and second-echelon lymph
nodes. Assuming that 20 % of the administered
activity has been absorbed in the RES systemically, the effective dose is calculated as 2 μSv/
MBq in a “worst-case” calculation [7, 14]. This
corresponds to 0.04 mSv after an injection of
20 MBq of 99mTc-labeled small colloid.
Although no dose values have been reported
for other applications besides breast cancer and
melanoma, it can be safely assumed that the
absorbed doses and effective doses for these procedures are in the same range [15, 16].
It should be noted that adoption of SPECT/CT
imaging protocols for SLN in melanoma will
increase both local radiation dose and effective
dose due to inclusion of the CT procedure, the
dosimetry being dependent upon both the site of
the melanoma and the CT acquisition parameters
selected. A low-dose CT scan with a field of view
limited to avoid radiosensitive tissues can help to
keep the effective dose to a minimum. For a lowdose CT for attenuation correction, for patients
undergoing a sentinel lymph node lymphoscintigraphy in breast cancer, an effective dose of
2.4 mSv has been reported [11]. The total exposure in such cases is the emission-generated dose
plus the transmission-generated effective dose.
fetus from a SLN examination will generally be
below the 1 mSv limit for increased stochastic
risk generally applied to fetal radiation hygiene.
Only in a melanoma located rather close to the
fetus (over the lower abdomen or back) the theoretical risk of exceeding 1 mSv is a relevant question. In such a case, the two important
modifications that may reduce fetal radiation
exposure will be (1) to reduce activity injected,
preferably less than 30–40 MBq, and to collect
the image data twice the normal duration and (2)
short time interval—always following a 1-day
protocol—from injection to operation [7].
6.3.3 Lactating Women
The presence of
reported, but it has been recommended in some
publications that lactation be suspended for nursing mothers for 24 h after radiopharmaceutical
administration, since radiocolloid will be excreted
from the breast milk during this period [18, 19].
99m
Tc in breast milk has not been
6.4 Patient Dosimetry for Other
Isotopes
In case of other isotopes (e.g., In-111 or F-18),
data for the patient exposure can be taken from the
corresponding ICRP tables ICRP [20–22] or from
the review article of Eberlein et al. [23]. For an
administered activity of 350 MBq F-18, the effective dose is 6.6 mSv, for 185 MBq In-111 10 mSv.
6.3.2 Pregnancy
Pregnant patients could be offered the SLN biopsy
after careful counseling regarding the safety and
efficacy of the procedure. According to international guidelines, the risk to the fetus is considered negligible for investigations exposing a fetus
to <1 mSv. Gentilini et al. report in breast cancer
patients that the estimated absorbed dose to the
embryo/fetus per unit activity is 5 μGy/MBq [17].
As reported also for melanoma [7], the dose to the
6.5 Staff Exposure for SLN
Diagnostics with Tc-99m
1
6.5.1 General Rules
Within the EU, national implementations of the
following EU Directives apply with respect to
1
This chapter is taken from the “EANM-EORTC general
recommendations for sentinel node diagnostics in melanoma” [7] and is reprinted with kind permission
of Springer Science + Business Media.
108
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M. Lassmann and U. Eberlein
radiation protection aspects of the clinical practice of nuclear medicine. Applying the 1990
Recommendations of the ICRP [4], the Basic
Safety Standards Directive (Council Directive
97/43/EURATOM 20072) enforces a general
radiation protection framework to ensure the
safety of employees and the public. The Medical
Exposures Directive (Council Directive 96/29/
EURATOM 20063) reinforces the need for justifi-
cation, optimization, and limitation of all exposures and places additional specific requirements
on stated duty holders, especially in respect to the
practical aspects of a medical exposure—its
referral, individual justification, and execution—
including the training and competence of all staff
whose actions contribute to the procedure(s)
performed.
6.5.2 Staff in Nuclear Medicine
Department
To comply with regulatory requirements, including those mandated by the Medical Exposures
Directive within the EU and those in force elsewhere [24], radiocolloid administration and preoperative diagnosis will be performed by trained
nuclear medicine personnel working in controlled environments. The administered activities
in lymphoscintigraphy are low compared with
those used in most other nuclear medicine procedures. Any increase in the occupational exposure
of nuclear medicine staff due to a SLN procedure
will be minimal as they are already categorized
as radiation workers. The highest doses received
by the hands of the staff have been recorded for
the physician who administers the tracer [25];
however, it is far below the ICRP annual dose
limits for the extremities of a radiation worker
[4]. One potential cause of significant exposure
exists however—if transmission imaging using a
radioactive
2
Replaced by Council Directive 2013/59/EURATOM
2013.
3
Replaced by Council Directive 2013/59/EURATOM
2013.
57
Co flood source is performed, the
source must not be held directly during image
acquisition.
6.5.3 Staff in Operating Room
Radiation exposure to operating room personnel
arising from the handling of radioactive specimens from SLN procedures is minimal. Studies
demonstrate that the occupational doses are
insignificant, the mean whole body dose received
by surgical staff has been measured to be <1 μSv
per operation [8, 26–28], with the maximum
effective dose to the surgeons involved reported
to be <2 μSv [8, 29] [30] . The radiation dose to
the hands of the surgeon has been estimated to be
5–94 μSv per patient [14]. When the surgical procedure is performed 24 h after injection, the
absorbed doses to the hands of the medical staff
may potentially be minimized [25, 31]. The monitoring of operating room personnel for occupational exposure to radiation is unnecessary during
sentinel lymph node biopsy. Additional shielding
and monitoring devices are not required in the
operating room.
6.5.4 Pregnant Staff
in Operating Room
One circumstance requiring specific consideration is that of the pregnant female surgeon or
scrub nurse regularly performing or assisting the
procedure. A pregnant surgeon who participates
in <100 SLN operations will stay below the limit
of radiation exposure as recommended for pregnant women [28].
6.5.5 Staff in Pathology
Department
The pathology staff usually spends a shorter time
manipulating the radioactive tissue specimens
than the does the surgeon and at a longer time
interval after injection; their exposure will therefore be lower. Even personnel performing an
unusually high number of procedures receive
6 Radiation Safety and Dosimetry
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109
radiation doses well below established limits for
members of the general public [32]. Under any
circumstances, radiation exposure to the pathology staff is low and should not normally require
badge monitoring.
6.5.6 Radiation Safety Precautions
Labeling the pathology specimens – When transporting the specimens to the laboratory, many
institutions seal them in suitable containers with
outer labels indicating radioactive content [31];
however, labeling is not required if the surface
dose rate is <5 μGy/h [33]. Even if an institution
does not label specimens, all personnel handling
them must be properly trained and authorized
and the specimens should be transferred promptly.
6.5.7 Radioactive Clinical Waste
While surgical instruments and pathology slides
appear to stay at background radiation levels,
measurable contamination of absorptive surgical
sponges and other materials used in the handling
of radioactive tissues is observed, especially
when they are used in the vicinity of the injection
site [8, 34]. Although a negligible contamination
hazard, this would constitute radioactive clinical
waste. It is advisable to monitor these materials
for contamination, and if contaminated, the trash
should be held for decay-in-storage before
disposal.
FDG-radioguided surgical procedures after
administration of around 700 MBq.4 The authors
report on a mean effective dose per case of
0.2 mSv received by the surgeon. Lower doses
are reported for the anesthetist, scrub technologist, postoperative nurse, circulating nurse, and
preoperative nurse. This exposure is, on a per
case basis, rather low. However, for larger patient
numbers, individual monitoring of exposure and
contamination should be considered.
For In-111-labeled compounds, there are,
unfortunately, at present no systematically collected exposure data available for SLN procedures. Therefore, one should also consider
monitoring the staff in this case (see also
Table 6.2).
6.7 Discussion and Conclusion
Radiolocalization of SLN with Tc-99m is associated with low levels of radiation exposure.
Radiation exposure monitoring or limitation of
the number of performed SLN procedures as well
as additional shielding is not required for staff in
the operating room and pathology department. In
principle, there is no contraindication for SLN
biopsies in pregnant patients; it is, however, common to reduce the activity. For radiopharmaceuticals with longer half-lives and/or positron
emitters, individual monitoring of staff exposure
and contamination should be considered for
larger patient numbers.
6.6 Staff Exposure for Other
Isotopes
As discussed previously, the radiation exposure
to personnel from low activities of Tc-99m for
sentinel lymph node procedures is low. These
results should not be applied to the use of other
radiopharmaceuticals and considerably higher
activities of Tc-99m.
For F-18-FDG, Povoski et al. [35] report on
the occupational radiation exposure to intraoperative and perioperative personnel from F-18-
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Safety
FDG
Nucl Med
Part III
https://t.me/med1917
Clinical Application: Breast
Radioguided Sentinel Lymph Node
https://t.me/med1917
Mapping and Biopsy in Breast
C a n c e r
Andrea V. Barrio and Hiram S. Cody III
7
Contents
7.1 Introduction 115
7.2 Lymphatic Drainage Patterns in the Era
of Modern Lymphoscintigraphy 116
7.3 Isotope Mapping Agents 116
7.4 Particle Size 116
7.5 Technique of Isotope Injection 117
7.5.1 Volume of Injection 117
7.5.2 Timing of Injection 118
7.5.3 Location of Injection 118
7.5.4 Superfi cial Versus Deep Injection 119
7.6 Isotope Versus Blue Dye 119
7.7 Technique of SLN Biopsy 119
7.7.1 Extra-axillary Drainage 120
7.7.2 SLN Biopsy After Neoadjuvant
Chemotherapy 120
7.8 The Memorial Sloan Kettering Cancer
Center Approach 121
Conclusion 121
References 122
Abstract
The histologic status of the axillary lymph
nodes remains one of the most important
prognostic indicators in breast cancer and
impacts recommendations for adjuvant therapy. Axillary lymph node dissection, once
considered standard care for axillary staging
in all patients with breast cancer, has been
largely replaced by sentinel lymph node
(SLN) biopsy in patients with a clinically negative axilla and in a select group of patients
with node- positive breast cancer. The SLN
can be mapped using radioisotope, blue dye,
or a combination of both, utilizing a variety of
injection techniques with comparable results
and similar false-negative rates. In this chapter, we will review the lymphatic drainage patterns of the breast, the technique of SLN
biopsy (with particular attention to the radiosurgical aspects), and the clinical implications
of the results.
7.1 Introduction
A. V. Barrio • H. S. Cody III ()
Breast Service, Department of Surgery ,
Memorial Sloan Kettering Cancer Center ,
300 East 66th Street , New York , NY , USA
barrioa@mskcc.org; codyh@mskcc.org
e-mail:
© Springer International Publishing Switzerland 2016
K. Herrmann et al. (eds.), Radioguided Surgery: Current Applications and Innovative
Directions in Clinical Practice, DOI 10.1007/978-3-319-26051-8_7
The histologic status of the axillary lymph
nodes remains one of the most important prognostic indicators in breast cancer and impacts
recommendations for adjuvant therapy.
Axillary lymph node dissection (ALND), once
considered standard care for axillary staging in
all patients with breast cancer, has been largely
115
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A.V. Barrio and H.S. Cody III
replaced by sentinel lymph node (SLN) biopsy
in patients with a clinically negative axilla and
in a select group of patients with node-positive
breast cancer. A study-level meta-analysis of
eight randomized controlled trials comparing
SLN biopsy to ALND demonstrated no difference in overall survival (hazard ratio
[HR] = 1.07), disease-free survival (HR = 1.00),
or regional lymph node recurrence (odds ratio
[OR] = 1.65) between SLN biopsy and ALND
[ 1 ], rendering ALND obsolete in clinically
node-negative breast cancer patients. The SLN
can be mapped using radioisotope, blue dye, or
a combination of both, utilizing a variety of
injection techniques with comparable results
and similar false-negative rates [ 2 , 3 ]. In this
chapter, we will review the lymphatic drainage
patterns of the breast, the technique of SLN
biopsy (with particular attention to the radiosurgical aspects), and the clinical implications
of the results.
7.2 Lymphatic Drainage Patterns
in the Era of Modern
Lymphoscintigraphy
was injected peritumorally; 93 % had axillary
drainage, but 50 % had non-axillary drainage
(most of these IM), and 7 % had isolated nonaxillary drainage [ 6 ]. Like Estourgie, Uren
found drainage to the IM nodes from all four
quadrants of the breast, suggesting that tumor
location alone is not the sole determinant of
non-axillary lymphatic drainage [ 6 ].
7.3 Isotope Mapping Agents
Technetium 99m—widely available, inexpensive, and with a low radiation dose—has become
the isotope of choice for SLN mapping in breast
cancer. A wide variety of carrier particles have
been used, as reviewed by Wilhelm et al. [ 7 ].
Technetium 99m sulfur colloid (Tc 99m sulfur
colloid) is the only registered radiopharmaceutical for lymphoscintigraphy in the United States
and therefore is the predominant radioisotope
used. Tc-99m-nanocolloidal albumin is widely
used in Europe and Tc-99m-antimony trisulfi de
colloid in Australia; both provide accurate localization of the sentinel node, but neither agent is
commercially available in the United States.
Modern techniques of lymphoscintigraphy
have defi ned the lymphatic drainage of the
breast with a new degree of precision. Estourgie
et al. have reported on 691 clinically node-negative breast cancer patients in whom 700 SLN
biopsy procedures were done, preceded by
lymphoscintigraphy using technetium
99m-nanocolloid injected directly into the
tumor. They observed axillary drainage in
95 %, internal mammary (IM) drainage in
22 % (usually in combination with axillary),
isolated IM drainage in 0–5.8 %, infraclavicular drainage in 2.7 %, interpectoral drainage in
2.2 %, supraclavicular drainage in 0.5 %, and
no lymphatic drainage in 3 % (Fig.
Axillary and IM drainage were observed from
all quadrants of the breast, but IM drainage
was more frequent and axillary drainage less
frequent from the lower inner quadrant
(Table 7.1 ) [ 5 ]. Uren et al. have reported on
217 breast cancer patients in whom isotope
7.1 ) [ 4 ].
7.4 Particle Size
The large particle size of Tc 99m sulfur colloid
(mean = 300 nm) raises theoretical concerns that
movement of this tracer beyond the injection
site into lymphatic vessels and nodes may be
limited. To overcome this potential liability,
many have advocated using “fi ltered” Tc 99m
sulfur colloid that has been passed through a
220 nm fi lter. A multi-institutional study by
Martin et al. demonstrated that the use of fi ltered or unfi ltered technetium sulfur colloid had
no impact on the number of sentinel nodes identifi ed, indicating that passage of the unfi ltered
colloid into the lymphatic system was not compromised by its larger particle size [
Moreover, in a study of 134 breast cancer
patients, Linehan et al. reported a superior sentinel node identifi cation rate with unfi ltered versus fi ltered isotope (88 % vs. 73 %, respectively;
8 ].
7 Radioguided Sentinel Lymph Node Mapping and Biopsy in Breast Cancer
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117
2.7 %‡
95.3 %∗
5.0 %∗∗∗
2.2 %
0.5 %∗∗
21.8 %†
2.4 %∗∗∗∗
Fig. 7.1 Drainage patterns of the breast identifi ed by
scintigraphy, showing overall lymphatic drainage ( n = 678)
(Adapted from Estourgie et al. [
Table 7.1 Lymphatic drainage pattern to the axilla and
internal mammary nodes by tumor location in early-stage
breast cancer patients ( n = 678)
Tumor
location
UOQ 96 10 2
UIQ 93 32 3
LOQ 98 30 1
LIQ 88 52 6
Central 100 24 0
Adapted from Estourgie et al. [
IMN internal mammary node, UOQ upper outer quadrant,
UIQ upper inner quadrant, LOQ lower outer quadrant,
LIQ lower inner quadrant
Axillary
drainage (%)
4 ]) *axillary; † internal
IMN
drainage (%)
5 ]
IMN drainage
only (%)
p = 0.03) [ 9 ]. The most frequent reason for failed
localization in the fi ltered group was a diffusely
“hot” axillary bed, not the failure to fi nd a single
“hot” node [ 9 ].
n = 678
mammary; ‡infraclavicular; **supraclavicular; ***lateral
intramammary region; ****medial intramammary region;
→ interpectoral
7.5 Technique of Isotope
Injection
A wide variation in isotope technique has been
reported in the literature with seemingly similar
success and false-negative rates. Technique varies with respect to volume, timing, location
(intraparenchymal, subareolar, or intradermal),
and depth of injection, although early sentinel
node studies reported similar outcomes despite
this wide variation [ 2 ].
7.5.1 Volume of Injection
The volumes of radioisotope injection reported in
the literature range from 0.05 to 16 mL, suggesting that the optimal volume for injection has not
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A.V. Barrio and H.S. Cody III
been determined [ 10 ]. Proponents of low-volume
injection argue that the normal lymphatic physiology is not disrupted by the small volume, with
Tanis et al. reporting an identifi cation rate of
99 % with 0.2 mL volume of tracer [ 10 ].
Advocates of larger-volume injection report
higher identifi cation rates [ 11 ], although many
have observed that the larger injection site “hot
spot”/”blast zone” may interfere with both lymphoscintigraphy and with the identifi cation of
nearby SLNs at surgery. Regardless of volume,
SLN identifi cation rates in large contemporary
studies are high (93–98 %), and there is no standard for volume of injection [ 10 ].
7.5.2 Timing of Injection
Blue dye travels quickly from the injection site to
the SLN and is therefore injected in the OR
immediately prior to surgery. Radiocolloid can
be observed in lymphatics and nodes within minutes of injection, but scintigraphic images are
typically taken within 30 min to 2 h of injection.
Lymphatic mapping need not be done on the day
of surgery. Winchester et al. reported improved
sentinel node identifi cation with day-before mapping compared to same-day mapping (97 % vs.
83 %) and a comparable number of SLNs
obtained (2.8 vs. 3.8) [ 12 ]. McCarter et al. com-
pared day-before with same-day isotope injection
and found no difference in the SLN identifi cation
rate or number of SLNs obtained, but observed
that day - before injection must account for the 6 - h
half - life of Tc 99m ; by giving 0.5 mCi to daybefore and 0.1 mCi to same-day patients, the
authors observed comparable isotope counts at
surgery [
13 ].
7.5.3 Location of Injection
Location of injection varies widely among institutions, with studies reporting intradermal, subdermal, subareolar, peritumoral/intraparenchymal,
and intratumoral injections. A nonrandomized
study of 298 patients comparing intradermal
( n = 164) to intraparenchymal ( n = 134) isotope
injection at our institution demonstrated a higher
sentinel node identifi cation rate with intradermal
versus intraparenchymal injection (98 % vs.
14 ]. A recent meta- analysis of 183 sentinel
89 %) [
node articles, which included patients with a
pathologically negative SLN followed by a completion ALND, compared 4 single-site injection
locations (peritumoral, subareolar, intratumoral,
and intradermal) and 3 multiple site injection
locations (peritumoral and intradermal, peritumoral and areolar, and intradermal and areolar)
and analyzed false-negative rates by injection
location. No signifi cant variation in false-negative
rate was identifi ed between these location categories ( p = 0.95) [ 3 ]. Although there was a trend
toward a lower numerical false- negative rate with
intratumoral (2.5 %) and intradermal (5 %) injection, there were too few cases to establish signifi cance, and therefore no “best” location site for
injection could be recommended [ 3 ]. Two ran-
domized studies have compared localization of
the SLN by injection route. Povoski et al. randomized 400 breast cancers to intradermal (ID)
( n = 133), intraparenchymal (IP) ( n = 134), or sub-
areolar (SA) ( n = 133) injection with approxi-
mately 0.4 mCi of fi ltered Tc 99m sulfur colloid.
SLN localization by preoperative lymphoscintigraphy was signifi cantly higher in the ID group
compared to the IP and SA group [95 % (ID) vs.
62 % (IP) vs. 72 % (SA); p < 0.001]. Intraoperative
SLN identifi cation was also signifi cantly higher
in patients receiving ID injection (100 %) compared to IP (90 %) or SA (95 %). Mean time to
fi rst localization and time to harvest fi rst SLN was
signifi cantly decreased with the ID injection route
compared to IP and SA routes, confi rming the
superiority of the ID injection route for SLN
biopsy in breast cancer patients [
FRANSENODE trial prospectively randomized
449 early-stage (T0–T1) breast cancer patients to
peritumoral injection (PT) versus periareolar (PA)
injection with unfi ltered Tc 99m sulfur colloid.
The authors reported a higher SLN detection rate
by lymphoscintigraphy with PA injection [85 %
(PA) vs. 73 % (PT); p = 0.03]; however, no signifi -
cant difference in intraoperative SLN identifi cation was noted by method of injection ( p = 0.16).
It should be noted that the method of PA injection
15 ]. The
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