Brachytherapy 16 (2017) 949e955

Gynecology Oncology

Rectum and bladder spacing in cervical cancer brachytherapy

using a novel injectable hydrogel compound
Antonio L. Damato1, Megan Kassick2, Akila N. Viswanathan3,*
1
Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY
2
Tufts Medical School, Boston, MA
3
Department of Radiation Oncology and Molecular Radiation Science, Johns Hopkins Medicine, Baltimore, MD

ABSTRACT PURPOSE: The aim of this study was to evaluate injection of a novel hydrogel (TraceIT; Augme-
nix, Waltham, MA) between the cervix, rectum, and bladder in female cadavers compared with, and
in addition to, the current standard of gauze packing, for organ-at-risk sparing in cervical cancer
brachytherapy planning.
METHODS AND MATERIALS: This brachytherapy cadaver study used T2-weighted MRI and
CT imaging to compare three scenarios: (1) gauze packing alone, (2) hydrogel injection placed in
the cervical fornices and rectovaginal septum, and (3) gauze packing in conjunction with hydrogel
injection. Hydrogel distribution was evaluated. Doses to 2 cm3 volumes (D2cc) for the rectum,
bladder, and sigmoid were collected. Statistical significance ( p ! 0.05) was evaluated using a
two-tailed paired t test.
RESULTS: Hydrogel was successfully injected to space the bladder and rectum from the cervix in
all five cadavers. The spacer was easily identifiable on both CT and MRI. The use of hydrogel
in addition to packing resulted in a 22% decrease in rectum D2cc dose ( p 5 0.02), a 10% decrease
in bladder D2cc ( p 5 0.27), and no change in sigmoid D2cc dose. No difference was observed be-
tween hydrogel only vs. gauze packing only.
CONCLUSIONS: Our results revealed a significant clinically meaningful decrease in rectal D2cc
associated with the use of hydrogel in addition to gauze packingdTraceIT hydrogel holds promise
as a spacer in cervical cancer therapy. 2017 American Brachytherapy Society. Published by
Elsevier Inc. All rights reserved.
Keywords: Cervical cancer; Gynecologic cancers; Chemoradiotherapy; Brachytherapy; Radiotherapy planning; Hydrogel;
Organs at risk; Rectum sparing; Bladder sparing

Introduction late gastrointestinal toxicities, which can greatly affect

quality of life, are associated with RCTX (3, 4).
The current standard of care for locally advanced cervi-
The standard method for dose sparing to the rectum
cal carcinoma is primary chemoradiation therapy (RCTX),
and bladder in cervical cancer brachytherapy is the place-
which includes both external beam and brachytherapy com-
ment of gauze packing in the vagina (5). In gynecologic
ponents to the radiation (1). Compared with previous stan-
cancer patients, one method that has gained recognition
dards, factors including radiation therapy only, local
is the use of a polyethylene glycol hydrogel for dose
control, progression-free survival, and overall survival are
reduction to organs at risk, particularly the rectum, partic-
improved with brachytherapy (2). These benefits, however,
ularly in the setting of re-irradiation (6). One absorbable
are not without accompanying side effects. Both acute and
spacer significantly reduces late toxicity by expanding in
the perirectal space (SpaceOAR system; Augmenix, Wal-
tham, MA). This spacer has been shown in multi-
Received 13 December 2016; received in revised form 19 March 2017; institutional clinical trials to result in increased perirectal
accepted 13 April 2017. space in prostate cancer patients, subsequently leading to
* Corresponding author. Department of Radiation Oncology and Mo-
rectal dose reductions and reductions in rectal toxicity
lecular Radiation Science, Johns Hopkins Medicine, 401 North Broadway,
Baltimore, MD 21231. Tel.: 1-410-502-1421. severity (7, 8). Recently, TraceIT hydrogel (TH; Augme-
E-mail address: anv@jhu.edu (A.N. Viswanathan). nix, Waltham, MA), a novel iodinated polyethylene glycol
1538-4721/$ - see front matter 2017 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.brachy.2017.04.236
950 A.L. Damato et al. / Brachytherapy 16 (2017) 949e955

hydrogel with multimodality visibility for 3 months, was Contouring

introduced. This particular hydrogel material has been as-
sessed as a marker in cervical cancer brachytherapy but
has not yet been assessed as a spacer in clinical trials in
gynecologic cancers (9).
The aim of this study was to evaluate TH injection be-
tween the cervix, rectum, and bladder in female cadavers
compared with, and in addition to, the current standard of
gauze packing, for organ-at-risk sparing in cervical cancer
radiation therapy planning. This will provide the first sup-
porting evidence that TH may be tested in the future as a
spacer in cervical cancer radiation therapy.
Methods and materials
As a part of this study, five cadavers were evaluated us-
ing CT and MRI.
The imaging, injection, and amount of material for ca-
davers are summarized in Table 1 and detailed in the sup-
plemental online information. The first cadaver was
evaluated without an applicator in place as a control to test
the feasibility of the cadaver model. The subsequent
four cadavers were implanted with a tandem and ovoids
(n 5 1) or a ring (n 5 3) and received a series of CT/
MRI with varying amount of gel inserted, with or without
standard vaginal packing. More details about the gel inser-
tion are presented in the Appendix. Distribution of the
spacer was evaluated through visual inspection of CT and
MRI.
A study of the effect of the use of the spacer on the
organs-at-risk dose metrics was performed. Three CT series
per cadaver were used: CT with applicator and packing
(packing only), CT with applicator and the maximum
amount of gel inserted (gel only), and CT with applicator
and both gel and packing (packing and gel). Axial and
sagittal T2-weighted MRIs with applicator in place after
gel injection were also available. The MRIs of Cadaver 5
were not used because of an artefact noted between the
rectum and the ring applicator that prohibited accurate
contouring.
The bladder, sigmoid, and rectum and gel spacer were
contoured when present. A comprehensive review of the
contours on the multiple image sets (CT and MRI) was per-
formed to ensure accuracy. This review was performed for
each patient to confirm consistency in contouring practice
(including delineation of the rectum/sigmoid interface)
among scans. Given that there was no tumor present in
the cadavers, no contouring of the cervix was attempted.
Planning
All CT image sets under investigation were recon-
structed with the applicator in the Oncentra Brachytherapy
Planning System (Nucletron, an Elekta Company, Stock-
holm, Sweden). The intrauterine tandem was digitized
manually in all image sets. The ovoids in the three image
sets of Cadaver 2 were also digitized manually, whereas
the ring in Cadaver 3, 4, and 5 were digitized using a
commissioned model of the applicator. A treatment plan
for a standard pear-shaped dose distribution normalized to
Point A was created on each plan. Loading pattern and
dwell weight were based on a previous study (10). This
planning approach reflects our clinical standard for a start-
ing plan in cervical cancer brachytherapy, before
optimization.
Analysis
The three-dimensional dose distribution for each plan
was calculated and exported to Eclipse treatment planning
system for evaluation. Doses to 2 cm3 volumes (D2cc) for
the rectum, bladder, and sigmoid were collected. To
compare the differences between the three scenarios under
investigation (packing only, gel only, as well as packing and
gel), a comparison of the D2cc as a percentage of a nominal
prescription dose was performed. Increases and decreases
in D2cc are described as the simple difference between
the percentage values of the metrics in the scenarios being
evaluated. To evaluate the clinical relevance of the differ-
ences between the three scenarios, a hypothetical treatment
course of 1.8 Gy  25 fractions in external beam followed

Table 1
CT evaluation of organs-at-risk D2cc as a percentage of the brachytherapy prescription dose
Rectum D2cc (% Rx) Bladder D2cc (% Rx) Sigmoid D2cc (% Rx)
Case no. Packing only Gel only Packing and gel Packing only Gel only Packing and gel Packing only Gel only Packing and gel
2 80 63 59 64 53 66 60 57 69
3 60 63 37 78 79 53 21 22 23
4 98 114 61 17 47 22 61 54 59
5 65 69 51 134 94 92 51 47 45
Mean 76 77 ( p 5 0.84) 52 ( p 5 0.02) 73 68 ( p 5 0.74) 58 ( p 5 0.27) 48 45 ( p 5 0.10) 49 ( p 5 0.89)
Standard 17 25 11 48 22 29 18 16 20
deviation
D2cc 5 doses to 2 cm3 volumes; Rx 5 prescription dose.
The statistical significance of the difference between the mean D2cc using gel (with or without packing) vs. using gauze packing is reported.
 A.L. Damato et al. / Brachytherapy 16 (2017) 949e955
by a brachytherapy course of 5.5 Gy  5 fractions was
assumed. Total D2cc metrics were recalculated using the
equivalent dose in 2 Gy (EQD2) formula. A tolerance of
70 Gy (EQD2) for rectum and sigmoid and 90 Gy
(EQD2) for bladder was assumed. Fractionation schedule,
EQD2 methodology, and dose tolerances reflect our own
clinical practice. Statistical significance ( p ! 0.05) was
evaluated using a two-tailed paired t test.
Hydrogel shift
To evaluate changes in hydrogel location after the injec-
tions, a registration was performed between MRIs and cor-
responding CTs based on rigid fusion of the bony anatomy.
The anatomy registrations were used to evaluate the
changes in location of the gel injected anterior to the rectal
wall. The distances between the superior edges (slice coor-
dinate in MRIeslice coordinate in CT) of the hydrogel and
the distance between the inferior edges of the hydrogel
were calculated. The time elapsed between CT and MRI
was obtained by looking at the timestamp of the images
in the Digital Imaging and Communication in Medicine
(DICOM) headers.
Results
Gel distribution and visibility
For all five cadavers, injections (minimum 5 cc) were
visible under CT and MRI, enabling distribution analysis.
For Cadaver 1, the injection near the rectum appeared to
spread after the second injection. For Cadaver 2, initial place-
ment of TH was unsatisfactory in distribution, but the second
round of injections remained localized. For Cadaver 3, the
posterior fornix injection remained localized, but the first
anterior fornix injection entered the intraperitoneal cavity.
The second anterior fornix injection remained localized.
For Cadaver 4, the anterior fornix distribution was satisfac-
tory, but the posterior fornix required additional injections.
Injections in Cadaver 5 resulted in satisfactory placement
but with some material in the vagina. Contouring was feasible
on CT and MRI, and review of the contours indicated good
visibility of the TraceIT spacer in both imaging modalities.
Table 2
MRI evaluation of organs-at-risk D2cc as a percentage of the brachytherapy prescription dose
Rectum D2cc (% Rx)
Case no. Packing only Gel only Packing and gel
2 N/A 52 46
3 N/A 55 39
4 N/A 69 47
Mean N/A 59 44 ( p 5 0.09)
Standard deviation N/A 9 4
D2cc 5 doses to 2 cm3 volumes; N/A 5 not available; Rx 5 prescription dose.
The statistical significance of the difference between the mean D2cc using gel (with or without packing) vs. using gauze packing is reported.
951
Dose metrics
Cadaver 1 was imaged without an applicator in place
and was, therefore, not evaluated for dose metrics. The
MRIs of Cadaver 5 were not used because of an artifact
located by the rectum and the ring applicator. D2cc metrics
in all scenarios for all Cadavers (2e5) are reported in
Table 1 (CT) and Table 2 (MRI).
A representative dose distribution is shown in Fig. 1. No
statistical significance in dose difference was observed in
between the uses of TH only versus packing only for
D2cc rectum, bladder, and sigmoid. The use of TH instead
of gauze packing resulted in a decrease in rectal D2cc dose
for Case 2 and a slight increase in all other cases. On visual
inspection of the images, the increase in rectal dose
occurred despite the increased space between the posterior
portion of the applicator and the rectal wall. This increase
appeared because of the location of the spacer, posterior
to the applicator with no spacing on the inferior side. This
configuration allowed in three of the five cadavers a defor-
mation of the rectum, allowing it to move closer to lateral
high-dose regions in the inferior region of the applicator
(Fig. 2). The difference in applicator may explain the differ-
ence between Cadaver 2 and the other cadavers.
The use of TH in addition to packing resulted in a
decrease of 22% of the prescription dose in rectum D2cc
dose ( p 5 0.02). A 10% decrease in bladder D2cc
( p 5 0.27) and a virtually identical (4% increase,
p 5 0.89) sigmoid D2cc were also observed. When TH
was used in addition to the vaginal packing, a statistically
significant 14 Gy (EQD2) decrease in rectal metrics was
observed ( p 5 0.03), along with a 12 Gy (EQD2)
decrease in bladder D2cc ( p 5 0.27) and an equivalent
sigmoid D2cc ( p 5 0.84). Results are reported in
Table 3. The EQD2 analysis showed that all cadavers
met rectal tolerance when TH was used in addition to
packing, whereas two cadavers exceeded tolerance with
packing only. D2cc doses calculated on MRI contours
compared with CT contours for the same patients showed
a lower dose for rectum: MRI was 11 Gy lower than CT
for gel only, and MRI was 4 Gy lower than CT for pack-
ing and gel; bladder: MRI 8 Gy lower than CT for gel on-
ly, and no difference for packing and gel; and a small
difference was noted for sigmoid: MRI 2 Gy higher than
Bladder D2cc (% Rx) Sigmoid D2cc (% Rx)
Packing only Gel only Packing and gel Packing only Gel only Packing and gel
N/A 51 55 N/A 73 59
N/A 45 57 N/A 40 35
N/A 32 34 N/A 35 37
N/A 43 49 ( p 5 0.20) N/A 49 44 ( p 5 0.35)
N/A 9 13 N/A 20 13
952 A.L. Damato et al. / Brachytherapy 16 (2017) 949e955

Fig. 1. Comparison of the position of the rectum contoured in brown with packing (left) and with gel alone with no packing inserted contoured in pink (right)
for Case 2. The 100% isodose line from the standard plan is in red. The bladder is contoured in yellow and the sigmoid in blue.

CT for gel only and MRI 4 Gy lower than CT for packing Discussion
and gel. No statistical significance was observed between
Unique in radiation oncology, historically, gauze pack-
MRI and CT dose metrics.
ing has been the standard of care for organ-at-risk sparing
MRI scans were performed before and after applicator
in cervical cancer brachytherapy and has allowed dose
insertion. The contours on the MRI scans were used to eval-
escalation to values more than 80 Gy to the primary tumor.
uate the positioning of the hydrogel spacer approximately
We previously published the clinical use of hydrogel
1 h after the original injection. The changes in TH location
spacing in patients treated with interstitial brachytherapy
compared with the surrounding bony anatomy were all !
for gynecologic cancers in the setting of reirradiation (6).
1 cm and are reported in Table 4.
Recently, polyethylene glycol hydrogel spacers have shown

Fig. 2. Comparison of the position of the rectum and bladder with packing (left) and with gel contoured in pink (right) for Case 3. TraceIT hydrogel is visible both
anteriorly pushing against the bladder and posteriorly pushing against the rectum (right). The 100% isodose line is in red. Bladder is contoured in yellow and
rectum in brown.
 A.L. Damato et al. / Brachytherapy 16 (2017) 949e955 953

Table 3
Organs-at-risk D2cc, calculated in Gy (EQD2) assuming a 1.8 Gy  25 fractions external beam course and a 5.5 Gy  5 fractions brachytherapy boost
Rectum D2cc (Gy) Bladder D2cc (Gy) Sigmoid D2cc (Gy)
Case no. Packing only Gel only Packing and gel Packing only Gel only Packing and gel Packing only Gel only Packing and gel
2 76 66 63 66 60 67 64 63 69
3 64 65 54 75 75 60 48 48 48
4 85 93 65 47 58 48 64 61 63
5 67 69 59 119 86 84 59 58 57
Mean 74 73 ( p 5 0.88) 60 ( p 5 0.03) 77 70 ( p 5 0.51) 65 ( p 5 0.27) 59 57 ( p 5 0.10) 59 ( p 5 0.84)
Standard 11 13 5 31 13 15 8 6 9
deviation
D2cc 5 doses to 2 cm3 volumes; EQD2 5 equivalent dose in 2 Gy.
The statistical significance of the difference between the mean D2cc using gel (with or without packing) vs. using gauze packing is reported. Doses were
calculated on the CT contours.

a significant benefit in toxicity reduction in prostate cancer
patients (7, 8). The aim of this study was to evaluate TH in-
jection between the cervix, rectum, and bladder in female
cadavers compared with, and in addition to, the current
standard of gauze packing, for organ-at-risk sparing in cer-
vical cancer radiation therapy planning. Although TraceIT
has been used as a marker in gynecologic cancer brachy-
therapy (9), this is the first study assessing TH as a spacer
in gynecologic cancers.
In this cadaver study, we found a statistically significant
clinically meaningful decrease in rectal D2cc associated
with the use of TH in addition to traditional gauze packing.
This result, if confirmed in patients, can potentially have an
impact in toxicities and clinical practice, as exceeding the
rectal tolerance is in many cases a limiting factor in plan-
ning. Potentially, the reduction in rectal dose may translate
into the possibility of obtaining a higher clinical target vol-
ume (CTV) dose to 90% of the volume (D90) without
increasing rectal dose, thus improving the therapeutic ratio.
A similar reduction in bladder D2cc was also observed, but
the size of this study does not allow inferring the statistical
significance of this finding. Moreover, the bladder D2cc
reduction appears to be less clinically meaningful because
of the higher tolerance of the bladder. A roughly equivalent
sigmoid D2cc dose in the two scenarios was expected
because of the generally more superior location of the sig-
moid compared with the injection site of the TH.
Our results are in contrast with a study from 2012 that
assessed hydrogel instillation in locally advanced cervical
cancer patients, looking at the feasibility of hydrogel appli-
cation and rectal toxicity reduction in patients undergoing
RCTX (11). This study, by Marnitz et al. (11), on 5 patients
showed that 20 cc of hydrogel did not improve rectal sep-
aration and thus rectal dose sparing in cervical cancer pa-
tients. A quantitative dose metrics analysis is not present
in that study; therefore, comparison of those results to ours
is limited. A main difference between the two injection
methodologies is that Marnitz et al. (11) injected the spacer
5 days before brachytherapy. Our injection was performed
during the brachytherapy applicator positioning and was,
therefore, targeted to provide rectal sparing for the brachy-
therapy boost.
The injection of hydrogel material in gynecologic can-
cers has not been fully standardized. We previously
described an injection for interstitial brachytherapy cases
using ultrasound guidance (6). In this tandem-based study
on cadavers, visualizing with ultrasound was more difficult
at the depth required, posteriorly by the sigmoid colon and
anteriorly, which would require use of a transabdominal
rather than transrectal probe. Injection of the material in

Table 4
Shifts of the inferior and superior borders of the gel injected anterior to the rectal wall between CT and the corresponding MRI
Gel only Packing and gel
Time elapsed between Time elapsed between
Case no. CT and MRI (min) Inferior border Superior border CT and MRI (min) Inferior border Superior border
2 71 0 0.4 47 0.8 0.4
3 64 0.4 0.4 39 0.8 0.8
4 60 0.4 0 37 0.4 0
5 N/A N/A N/A N/A N/A N/A
Mean 65.0 0.0 0.3 41.1 0.7 0.4
N/A 5 not available.
All injections and imaging occurred after applicator placement. Positive values indicate a superior shift from CT to MRI, and negative values indicate an
inferior shift from CT to MRI.
954 A.L. Damato et al. / Brachytherapy 16 (2017) 949e955
cadavers carries little risk, and it should be injected into the
rectal or bladder wall, whereas for patients, ultrasound
would be recommended to minimize this risk. In clinical
practice, the use of ultrasound may best assist with accurate
placement and should be considered for patients.
In addition, our study combined both hydrogel place-
ments when combined with gauze packing. Our results sug-
gest that rectal sparing with gauze packing achieved during
the brachytherapy boost is clinically significant even when
assuming no additional sparing from the external beam
treatment. The use of spacer for rectal sparing in prostate
cancer patients has become more common, and the dose
and toxicity reduction has been reported (7, 8, 12, 13).
Direct comparison of dose metrics is not possible because
of the different modalities.
The use of TH as an alternative to gauze packing re-
sulted in a small increase in rectal D2cc in three of the four
cadavers under investigation. The spacer, placed posteriorly
to the applicator, reduced the dose received there but did
not prevent the rectum from looping close to the side and
the inferior region of the applicator. Our study did not
attempt to optimize the dose distribution to account for
the looping, and clinical results can differ from those
observed in this study. Gauze packing provides further sep-
aration between the rectum and the inferior aspects of the
applicator, and the use of gauze packing and TH at the
same time achieves the overall reduction in rectum D2cc
that would be expected. In Cadaver 4, a portion of the
TH was injected at the posterior rectal wall in the inferior
area of the applicator, pushing the rectum upward toward
the applicator. Analysis of MRIs acquired after TH injec-
tion shows that the hydrogel remained mostly in its
anatomic location during that time. Although some changes
in spacer configuration were observed based on bony anat-
omy fusion, all shifts measured were !1 cm. Shifts in the
gel-only configuration, which is not confounded by the
presence of vaginal packing, were !4 mm. A small relative
shift between the applicator and spacer and surrounding
anatomy was noted. This shift was likely due to cadaver
manipulation between scans. In general, lower metrics were
observed when calculated on MRI contours, which were ac-
quired approximately 1 h after the CT, suggesting that shifts
and changes in applicator location may affect the dose dis-
tribution but, in our results, this degree of change did not
obviate the dose reduction effect of the spacer. Although
systematic differences in contouring are also possible
because of the different imaging modalities, these differ-
ences have been minimized by a careful contour review
performed jointly by a radiation oncologist and a physicist.
A limitation of this study was that we used only standard
pear-shaped plans, instead of optimized three-dimensional
plans. This approach was justified by the need to obtain a
fair comparison among the different scans under investiga-
tion and the fact that no cadaver had cervix cancer. An
anatomy-based optimization would have resulted in poten-
tial planning bias and in uncertainty because of different
CTV contouring. Moreover, it should be noted that non-
optimized planning, although not our clinical standard, is
still widely practiced in the United States and throughout
the world. Also, this study did not investigate possible
changes in CTV shape because of the presence of the
spacer. Finally, this is a cadaver-based feasibility study. In
general, cadaveric tissue may be considered less disten-
sible, although no cadaver had cervical cancer; the impact
of the localized fibrotic reaction caused by cancer on
injector spacing is unknown.
Conclusion
Our results revealed a significant clinically meaningful
decrease in rectal D2cc associated with the use of TH in
addition to traditional gauze packing. These findings pro-
vide the first supporting evidence that TH may be validated
as a spacer in cervical cancer therapy. Further studies may
provide additional supporting evidence. TH may have an
impact in clinical practice, reducing rectal toxicity and
improving quality of life for cervical cancer patients.
Acknowledgments
Material supplied by Augmenix, Inc, Waltham, MA. Dr
Viswanathan received support from NIH R21 167800.
Supplementary data
Supplementary data related to this article can be found at
http://dx.doi.org/10.1016/j.brachy.2017.04.236.
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