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designated area of the liver. Yttrium-90 has a half-life of 64.2 hours and the average energy
emitted is 0.9367 MeV. There are approximately 22,000 to 73,000 microspheres per milligram.3
The dose of the TheraSphere must be ordered for each patient and are available in dose sizes
from 3 GBq to 20 GBq in increments of 0.5 GBq. The TheraSphere comes in 0.05 mL of sterile,
pyrogen-free water contained in a 0.03 mL vee-bottom vial secured within a 12 mm clear acrylic
vial shield. The acrylic vial shield adds protection against leakage as well as the emitted
radiation. Yttrium-90 is a beta emitter and this thin acrylic will minimize the generation of
Bremsstrahlung radiation.
There are risks and benefits for patient treatments based on tumor extent and liver function.
TheraSphere treatment comes with risks of bleeding, infection, damage to bowel, stomach and
liver, and many other complications including death. Though in a study of the safety, tumor
response and survival of 43 patients who received TheraSphere treatment for HCC it was
reported that 79% of lesions indicated a response to the treatment, there were minor adverse
events mostly that coincided with disease progression. None of the events related to the
treatment were life threatening.4
Case Description
Patient Selection/ Eligibility
In order for a patient to receive TheraSphere treatment they must undergo appropriate
angiographic procedures such as a hepatic arterial catheterization using balloon catheterization to
prevent shunting outside of the liver. Using this procedure along with radiopharmaceutical
Technetium 99mTc microaggregated albumin, (Tc-99m MAA) the extent of arteriovenous
shunting to the lungs was determined as well as the volume of the liver that was treated. This
patient had a lung shunt fraction of 2.4%, the amount of liver determined to be treated was
2417.4 cc. A confirmation can be made regarding the absence of gastric and duodenal flow using
scintigraphic views of the stomach using air contrast. If there is any GI shunting, TheraSphere
treatment is no longer an option due to the risk of bowel damage. This patients gastrointestinal
shunt fraction was 0%. Once the patient was deemed eligible the calculation of dose and
ordering of the TheraSphere was completed.
Target Delineation
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The exact liver volume was determined by a Tc-99m MAA scan. After undergoing the
appropriate testing in Intravascular Radiology the patient volumes were determined as: lung
shunt fraction 2.4%, gastrointestinal shunt fraction 0%, right lobe volume 2417.4 cc, left lobe
volume 234.59 cc, total liver volume 2561.99 cc, and a target for infusion volume of 2417.4 cc to
the right lobe. The volumes were reported on an Intravascular Radiology worksheet (Figure 1).
The information must be submitted to the appropriate personnel in advance to allow adequate
time for calculations, ordering, delivery and assaying of the source before treatment may
commence.
Calculation
It is important to know the patients past medical history. Certain details must be known in order
to calculate the proper activity. Things such as previous external beam radiation, previous
brachytherapy and if the patient has cirrhosis can all change the desired dose to the designated
area of the liver. The average dose prescribed to the liver is between 80-150 Gy however, if the
patient is cirrhotic they will be prescribed a dose toward the lower end of the scale, between 80100Gy. If there is no cirrhosis the patient will likely be prescribed 100-150 Gy. Also the liver
mass and shunting values from the Tc-99m MAA scan play a role in dose limiting factors as
well. The lung can only receive a cumulative dose of up to 50 Gy in multiple treatments.5 By
using the formula in figure 2 the required activity is calculated. There were no indications of
cirrhosis or radiation therapies in this patients medical history. This patient received 7 Gy to the
lung and 112 Gy to the treatment site in the liver.
TheraSpheres are calibrated for a certain day, typically Sundays at noon. Due to the specific
calibrations the orders must be placed the week prior to the actual injection. The infusion date
and time must be specified before ordering the TheraSphere. The required activity at time of
infusion should be decay corrected.
Before ordering, the actual dose to the liver was calculated as well as the amount shunted to the
lungs. The lungs are limited to 30 Gy for a one time fraction or 50 Gy for a combination of
infusions. These doses could be limiting factors in some cases. For instance if the doctor has
prescribed the liver to receive 150 Gy the activity is calculated and put into the formula to
determine the lung shunting dose. If the lung shunting does exceed the limit, the activity will
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need to be decreased to stay within the lung dose limit which will in turn lower the maximum
amount of dose to the liver and the desired dose of 150 Gy will not be obtainable.
The formula
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potential for leakage of the radioactive material, all surfaces in the room that held the
TheraSphere were covered with absorbent covers prior to introduction of the TheraSphere. This
included the cart that held the administration kit, the path for the tubing that the Y-90 passed
through to the patient, and the area of the patient and radiography equipment where the Y-90 was
introduced. These covers presented an impermeable barrier on the side away from the Y-90
path, containing any radioactivity that could spill during the procedure. All personnel present for
the procedure wore appropriate radiation protection and monitoring equipment such as lead
aprons, personal radiation dosimeters, gloves, booties, and caps. All dosimeters were operational
to survey any object or person leaving the room once the TheraSphere was present, in addition to
obtaining an initial reading of the TheraSphere delivery apparatus.
Before patient administration, the TheraSphere Written Directive was completed with a
physician signature and the plans and calculations were checked by a physicist. The TheraSphere
Administration Set and TheraSphere Administration Accessory Kit were set up following verbal
instruction of the TheraSphere checklist (Figure 7). The Administration Set contained one sterile
disposable tubing set up and one empty sterile vial. The tubing set was pre-assembled with one
way valves, a needle plunger, and an integrated 20 cc syringe. This helps ensure all pieces are
sterile, assembled correctly, and the flush will flow in the appropriate direction only (Figures 4 &
5). The TheraSphere Administration Accessory Kit contained re-usable accessories including
an acrylic box base, top shield, removable side and top shields, bag hook and a RAD-60R
radiation dosimeter. Not only does this kit provide additional shielding, it is also the best setup
for monitoring the infusion process (Figure 5).
The TheraSphere checklist (Figure 7) was read aloud with verbal confirmation of each step
throughout the procedure. The administration of the TheraSphere was completed through a
minimum of three saline flushes with the 20 cc syringe provided and an approximate flow rate of
20 cc per minute until optimal delivery has been achieved. The 20 cc per minute is the
approximate flow rate of the hepatic artery and a flow rate less than that may decrease delivery
efficiency. The infusion pressure should not exceed 30 psig (pounds per square inch guage)
during any flush. The Administration Set had a pressure relief valve to help prevent over
pressurization. Optimal delivery was determined by monitoring the Administration Set with the
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RAD-60R radiation dosimeter provided. The ratio of the dose rate readings before and after
administration provided an estimation of dose delivered to the patient.
The actual percentage of dose delivered to the patient was calculated based on ion-chamber
radiation detector measurements of the dose prior to administration, compared to measurements
of the waste after administration. Before administration the acrylic shield containing the
TheraSphere vial was measured at a distance of 30 cm from the detector (Figure 8). After
administration the waste container inside the beta shield was measured at a distance of 30 cm
from the detector (Figure 9) at 4 rotational positions. These 4 measurements were averaged. The
percentage of dose delivered to the patient was calculated using the equation seen in figure 10.
Post-Administration Procedures
All materials used in the room during the infusion were surveyed prior to removal or disposal.
Since Y-90 is a beta emitter, appropriate procedures were followed using a Geiger-Mueller (GM)
survey meter with a pancake GM probe to allow detection of such contamination. Contaminated
materials such as the dose vial, tubing, catheters, and gauze were placed in the radioactive waste
container. All personnel in the room had their hands, feet, and any apparel surveyed before they
were allowed to exit the room. Once materials involved in the procedure were surveyed and
removed, a patient survey was completed to verify that there was no surface / skin
contamination. A radiation survey was also done to verify the dose rate at 1 meter from the
patient. A room survey was also done to verify no residual activity in the treatment room.
The patient proceeded to a recovery unit as a radioactive patient although the patient did not
present a risk to others for radiation exposure. Some contamination may be present in blood or
urine following the procedure. If the patient becomes hospitalized directly after the procedure
they will require a private room with private bathroom facilities but no other shielding or visitor
limitations will be necessary. Materials that come in contact with the patients blood or urine
need to remain within the room until surveyed and cleared. For example a Foley bag would need
to remain but the urine inside the bag could be flushed.
Conclusion
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There were many precautions taken for both the patient and the personnel involved with the
TheraSphere treatment procedure. The literature supports Y-90 or TheraSphere treatments safe
and effective for HCC patients.3, 5 Currently there is an ongoing clinical trial by the Sidney
Kimmel Comprehensive Cencer Center studying the safety and overall survival of patients with
liver metastases treated with TheraSpheres at doses of 120 +/- 10%, Intra-arterial Y-90
TheraSpheres for hepatic metastases from solid tumors NCT0117707. There were 15 events
reported out of 264 TheraSphere cases between the years 2001-2007.6 The report stated that 73%
of these events were device/product defects. Though events were only reported for 5.7% of the
cases, the use of appropriate procedures and precautions helped prevent additional complications
to the events as well as prevent additional events from occurring.
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References
1. Salem R and Hunter R. Yttrium-90 microspheres for the treatment of hepatocellular
carcinoma: a review. Int. J. Radiation Oncology Biol. Phys. 2006;66(2):s83-s88.
http://dx.doi.org/10.1016/j.ijrobp.2006.02.061
2. Abdalla EK and Keith SE. Overview of treatment approaches for hepatocellular carcinoma.
UpToDate, University of Michigan Med School Web site.
http://www.uptodate.com/contents/overview-of-treatment-approaches-for-hepatocellularcarcinoma. August 05, 2013. Accessed July 10, 2014.
3. Lewandowski RJ and Salem R. Yttrium-90 radioembolization of hepatocellular carcinoma
and metastatic disease to the liver. Semin Intervent Radiol. 2006;23(1):64-72.
http://dx.doi.org/10.1055/s-2006-939842
Figure 1. Worksheet showing liver volumes, lung shunt fraction and gastrointestinal shunt
fraction from Intravascular Radiology.
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Figure 2. Formula used to calculate the required activity needed to deliver the desired dose.
Figure 3. Formula used to confirm dose, where F is the fraction of injected radioactivity
localizing in the lungs, as measured by Tc-99m MAA scintigraphy. (F x A = 0.61 GBq).
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Figure 7. TheraSphere checklist read aloud during procedure with verbal confirmation all steps
have been completed.
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Figure 8. Acrylic shield containing the TheraSphere vial being measured at a distance of 30 cm
from the detector
Figure 9. Waste container inside the beta shield being measured at a distance of 30 cm from the
detector
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Figure 10. Formula used to calculate percentage of dose delivered to the patient