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2 Radiation Protection Dosimetry (2012), pp. 1 9 doi: /rpd/ncs TEDE PER CUMULATED ACTIVITY FOR FAMILY MEMBERS EXPOSED TO ADULT PATIENTS TREATED WITH 131 I Eun Young Han 1, *, Choonsik Lee 2 and Wesley E. Bolch 3 1 Department of Radiation Oncology, University of Arkansas Medical Sciences, 4301 West Markham Street #771, Little Rock, AR 72205, USA 2 Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institute of Health, Bethesda, MD 20852, USA 3 J. Crayton Pruitt Family Department of Biomedical Engineering, University of Florida, Gainesville, FL 32611, USA *Corresponding author: eyhan@uams.edu Received March , revised June , accepted June In 1997, the United States Nuclear Regulatory Commission amended its criteria under which patients administered radioactive materials could be released from the hospital. The revised criteria ensures that the total effective dose equivalent (TEDE) to any individual exposed to the released patient will not likely exceed 5 msv. Licensees are recommended to use one of the three options to release the patient in accordance with these regulatory requirements: administered activity, measured dose rate, or patient-specific dose calculation. The NRC s suggested calculation method is based on the assumption that the patient (source) and a family member (target) are each considered to be points in space. This point source/target assumption has been shown to be conservative in comparison to more realistic guidelines. In this present study, the effective doses to family members were calculated using a series of revised Oak Ridge National Laboratory stylised phantoms coupled with a Monte Carlo radiation transport code. A set of TEDE per cumulated activity values were calculated for three different distributions of 131 I (thyroid, abdomen and whole body), various separation distances and two exposure scenarios (face-to-face standing and side-by-side lying). The results indicate that an overestimation of TEDE per cumulated activity based on the point source/target method was >2-fold. The values for paediatric phantoms showed a strong age-dependency, which showed that dosimetry for children should be separately considered instead of using adult phantoms as a substitute. On the basis of the results of this study, a licensee may use less conservative patient-specific release criteria and provide the patient and the family members with more practical dose avoidance guidelines. INTRODUCTION In 1997, the United States Nuclear Regulatory Commission (USNRC) amended its regulations concerning the criteria for the release of patients who have been administered radioactive materials in 10CFR (1). The previous release criteria were based on an administered activity,1110 MBq or a dose rate,0.05 msv h 1 at 1 m (1). The revised criteria now allow licensees to release the patient if the estimated total effective dose equivalent (TEDE) to any other individual from exposure to the released patient is not likely to exceed 5 msv. Licensees should use one of three different options to demonstrate compliance with the regulatory requirements: administered activity, measured dose rate, and patient-specific dose calculations. NUREG-1556, Vol. 9. contains the tables of activities and dose rates not likely to cause doses exceeding 5 msv and describes the methods for calculating doses to other individuals (2). The USNRC adopted the equation of the integrated exposure over infinite time specified in NCRP Report No. 37 (3) as follows: D ¼ 34:6 GQ ot p OF r 2 ð1þ where D is the total dose from exposure to gamma radiation, 34.6 is the conversion factor of 24 h d 1 multiplied by the total integration of decay (1.44), G is the exposure rate constant for a point source in unit of C kg 21 cm 2 MBq 21 h 21, Q o is the administered activity in MBq, 34.6 Q o T p is equal to the cumulated activity ~ A in MBq h, T p is the physical half-life of the radionuclide in days, r is a distance of the point source from the point of interest in meters and OF is the occupancy factor, which represents the fraction of the total time an individual spends at a distance of 1 m from the patient. When one rearranges Equation (1) after replacing D with 5 msv, the maximum administered activity (MBq) (Equation (2)) and the maximum dose rate at 1 m (msv h 1 ) (Equation (3)) can be derived as follows: 5 msv r2 Q o ¼ 34:6GT p OF ð2þ # The Author Published by Oxford University Press. All rights reserved. For Permissions, please journals.permissions@oup.com
3 and GQ o r 2 ¼ 5 msv ð3þ 34:6T p OF As of the third option for the patient-specific dose calculation, licensees can consider a retained activity in the patient, an occupancy factor of less than 0.25 at 1 m, an effective half-life and potential shielding by the patient. As described, all three options provided in NUREG-1556, Vol. 9, use the exposure rate constant G, defined as an exposure rate at a point 1 cm away from a point source with the activity of 1 g of radium (37 MBq ¼ 1 mci). That means that it is assumed that the patient (source) and an exposed individual (target) are each considered to be a point in space. This point source/target assumption ignores attenuation and scattering within the patient and within an exposed individual. It is impossible to take into account different body sizes of exposed individuals depending on ages and realistic source activity distributions inside the patient, which might not be uniformly distributed. These simplifications of the more realistic clinical situations may cause overly conservative estimates of family member doses. To address this issue, Siegel et al. (4) suggested a line-source model to determine doses to an individual exposed to a radioactive patient with an extended activity distribution. They found that the point source method is not suitable up to a certain distance between the patient and an exposed individual depending on the length of the line source. Sparks et al. (5) simulated two simplified mathematical phantoms by assuming the entire body to be a soft tissue using the Monte Carlo (MC) transport code MCNP4A, with the patient and an exposed individual facing each other and 1 m apart. In their work, the point source method was found to overestimate the dose equivalent per cumulated activity by a factor of 2.4. Using two female voxel phantoms in two different distances and orientations, de Carvalho et al. (6) calculated the organ and effective doses for a bystander exposed to the radioactive patient. Recently, they also reported the results of the organ and effective dose calculations using point, line and volume sources which highlighted the over-conservative results caused by the point source method (7). In this study, instead of using exposure rate constant, dose calculation was implemented on the basis of tissue-weighted individual organ doses of the agedependent computational phantom series as target phantoms (hereafter referred to as family members) through the MC transport method. The purpose of this study was to calculate (1) the maximum releasable administered activity in accordance with the E. Y. HAN ET AL. Page 2 of 9 regulatory limit of a 5 msv TEDE, and (2) TEDE per cumulated activity (msv MBq 21 h 21 ), using the MC radiation transport technique coupled with a series of paediatric and adult phantoms in various exposure scenarios. The calculations were undertaken only for 131 I, which is one of most commonly used radioisotopes in the medical use of radioactive materials (8). MATERIALS AND METHODS Revised Oak Ridge National Laboratory phantom series In this study, we employed a revised series of stylised computational phantoms (9) representing the ICRP reference 1, 5, 10 and 15-y-old and adult as previously published by the authors. Several revisions were incorporated into the original Oak Ridge National Laboratory (ORNL) stylised phantoms (10) : (1) insertion of newly published models of the head, brain, kidneys and rectosigmoid colon; (2) explicit delineations of respiratory and extra-pulmonary airways, salivary glands and mucosa layers of urinary bladder and alimentary tract; (3) reference values of elemental tissue compositions and mass densities from ICRP Publication 89 and (4) explicit treatment of left and right tissues within organ pairs. The revised ORNL adult and 15-y hermaphrodite phantoms were used to represent an adult male and a female, respectively, since the 15-y-old phantom was considered to be representative of an adult female (9). Calculations of TEDE per cumulated activity In 2009, the internal dosimetry of the Medical Internal Radiation Dose Committee of the Society of Nuclear Medicine published (11) a revised scheme for the assessment of the absorbed dose to a patient in the therapeutic nuclear medicine as follows. Dðr T Þ¼ ~ A s Sðr T r S Þ ð4þ where A ~ s is a total cumulated activity in the source organ of the patient and S(r T r S )isthes values defined as the mean absorbed dose per cumulated activity from the source organ, r S, to the target organ, r T, in the patient in mgy MBq h 1. Equation (4) is rearranged by replacing r T with an organ of the family member, r FM,T,andr S with a 131 I localisation area in the patient, r PT, to provide the effective dose. Dðr FM Þ¼ A ~ PT X w T Sðr FM; T r PT Þ ð5þ T where Sðr FM; T r PT Þ is the mean absorbed dose per cumulated activity for a specific organ T in a family
4 member exposed to the patient mgy MBq 21 h 21, which is equivalent to the S value in Equation (4). TEDE (msv) and the maximum releasable administered activity (Q o, MBq) can be derived from Equation (5) as Equations (7) and (8), respectively. TEDE ¼ 34:6Q o T P OF X T ¼ 34:6Q o T P OF X T w T Sðr FM; T r PT Þ ð6þ X E i n i fðr FM; T w T i m T 5 msv Q o ¼ 34:6T P OF P P E i n i fðr FM; T w T T i m T r PT Þ i r PT Þ i ð7þ ð8þ where w T is the tissue-weighting factor of International Commission on Radiological Protection (ICRP) Publication 60 (12) for an organ T, E i is the emitted photon energy from the radionuclide 131 I for the ith decay, n i is the radiation yield in ith decay, m T is the target organ mass (kg) and fðr FM; T r PT Þ is the absorbed fraction, which is defined as the fraction of radiation energy E i emitted within the source region of the patient, r PT, that is absorbed in an organ r FM,T in the target phantom. TEDE CALCULATION BY MONTE CARLO MC transport method A general purpose MC transport code, MCNP5 (13), was utilised in the calculations of this study to take into account the realistic source/target geometries and behaviours of radiation particles such as attenuation and scattering. The revised ORNL phantom series were incorporated into the MCNP5 code and elemental tissue compositions and mass densities were also implemented into the code. It is assumed that the radioactive source was uniformly distributed within each source region. Surface source writing file (also called as a phase space file) provided by MCNP5 was used to reduce calculation burdens that could be caused by employing two phantoms at the same time within the same transport medium. In this method, all particle tracks from a source phantom were recorded in the surface source file if an emitted photon crosses the predefined surface between two phantoms. In subsequent calculations, the particle information recorded in the surface source file would be used to irradiate various target phantoms without starting photons again from the source phantom. Monoenergetic photons with the energy ranging from 10 kev to 4 MeV were transported to calculate the absorbed fractions. A total of million photon histories were used to maintain relative errors Figure 1. Three-dimensional lateral views of two phantoms facing each other at various distances ranging from 0.1 to 2 m. Adult male patient phantom is facing 1, 5, 10 and 15-y-old phantoms. Skin and muscle tissues are removed to better visualise the internal organs and skeleton. Page 3 of 9 340
5 within the major organs in a target phantom at,5 %. Since dose deposition in a target phantom due to electron transport is small, mode P was selected. Additionally, the F4 tally was used to score the photon fluences to calculate the absorbed fraction in the red bone marrow and bone surface by applying the fluence-to-dose response function generated by Cristy and Eckerman (10). After a final set of energydependent absorbed fractions of a target phantom for each scenario (see section Scenarios of exposure ) was compiled from the MC calculation, TEDE (msv) per cumulated activity and the maximum releasable administered activity (MBq) were calculated from Equations (7) to (8), respectively and compared with the values by the point source method. A physical half-life (T p )of8.04dandanofof0.25wereused for all calculations. E. Y. HAN ET AL. Scenarios of exposure Three different 131 I source regions (thyroid, abdomen and whole body) in the adult phantom were considered since these 131 I activity localisations have been most likely observed in the patients after radioiodine therapies for hyperthyroidism, radioimmunotherapy, or differentiated thyroid cancer (8, 14, 15). The abdominal source region was defined as a volume covering the lower half of the torso of the adult male phantom. Only the adult male phantom was considered as a source phantom and different target phantoms including 1-, 5-, 10-, 15-y-old, and adult male phantoms were taken into account. Two exposure orientations were simulated: (1) an adult male patient is facing a family member at five different distances (0.1, 0.5, 0.75, 1 and 2 m) (Figures 1 and Figure 2. Three-dimensional depiction of the adult patient phantom (left) with 131 I localised in the abdominal region facing the other adult target phantom (right) at a 1 m distance. A total of 1000 initial photon tracks are visualised by using the Sabrina software and MCNP5. Skin and muscle tissues are removed to better view the internal organs and skeleton. Page 4 of 9 455
6 ) and (2) an adult male patient is lying with an adult female side by side at a distance of 0.3 m (Figure 3). RESULTS AND DISCUSSION Maximum releasable administered activity Table 1 presents the maximum releasable administered activity (MBq) at or below which the adult male patient may be released in the exposure scenario where the patient and a family member are facing each other at different distances when 131 Iis localised in thyroid, abdomen and whole body of the patient. Equation (8) was used to calculate the TEDE CALCULATION BY MONTE CARLO maximum releasable administered activity in accordance with the regulatory limit of 5 msv TEDE. A physical half-life of 8.04 d and an occupancy factor of 0.25 were assumed for these calculations. The maximum releasable activity increases as a distance increases except in the case of the thyroid source. The maximum releasable activities based on the point source/target method (Equation (2)) are lower by a factor of 2.3 on average than the values obtained in this study (Equation (8)). Realistically, licensees can release the adult male patient who has been administered even greater activity by a factor of 2.3 on average when the patient will be facing other family members at a 1 m distance. This finding is consistent with the results of Sparks et al. (5) and de Carvalho et al. (7) Figure 3. Three-dimensional frontal view of adult male patient phantom (left) with an adult female target phantom surrogated by a 15-y phantom side by side at a 0.3 m distance. Skin and muscle tissues are removed to better view the internal organs and skeleton. Page 5 of 9 570
7 E. Y. HAN ET AL. Table 1. Maximum releasable administered activity (MBq) when 131 I is localised within thyroid (THY), abdominal region (ABD) and whole body (WB) in the adult male patient phantom facing the family members with different ages (1, 5, 10, 15-y and adult) at different distances Distance (m) Point method Target phantoms 1 y 5 y 10 y 15 y Adult THY ABD WB THY ABD WB THY ABD WB THY ABD WB THY ABD WB The values (MBq) based on the point source/target method at corresponding distances are also included for realistic comparison Figure 4. TEDE per cumulated activity (msv MBq 21 h 21 ) as a function of the distance of an adult male patient from his family members with different ages facing the patient with 131 I localised in the thyroid Since the actual values of the maximum releasable activity will vary depending on different parameters such as OF, it is desirable for the readers to compare the two methods. TEDE per cumulated activity for patient-specific dose calculation Figures 4 6 show TEDE per cumulated activity (msv MBq 21 h 21 ) to paediatric and adult family members a a function of distance when 131 I is concentrated on thyroid, abdomen and whole body, respectively, in the adult male patient. The NRC default value based on the point source/target method at a 1 m distance is also shown for comparison. In Figure 4, TEDE per cumulated activity decreases rapidly with increasing distances and converges to a single value at 2 m. When a target phantom is a 1- or 5-y-old child, the values are small regardless of distance, which means that a child under the age of 5 y is barely affected by an adult male with the thyroid localisation while they stand on the ground. Figure 5 for the abdomen source region shows that the values decrease rapidly with increasing distances and Page 6 of 9
8 TEDE CALCULATION BY MONTE CARLO Figure 5. TEDE per cumulated activity (msv MBq 21 h 21 ) as a function of distance of an adult male patient from his family members with different ages facing the patient with 131 I localised in the abdomen Figure 6. TEDE per cumulated activity (msv MBq 21 h 21 ) as a function of distance of an adult male patient from his family members with different ages facing the patient with 131 I distributed over whole body converge to an asymptotic value at 0.75 m except in the case of a 1-y-old phantom. TEDE per cumulated activity of a 10-y-old phantom is larger than any other age phantoms, since the height of the phantom is comparable with the level of the abdomen region in the adult patient. General Page 7 of 9
9 E. Y. HAN ET AL. Table 2. TEDE per cumulated activity (msv MBq 21 h 21 ) from the simulation of an adult male patient lying with an adult female at a distance of 0.3 m. Distance (m) Point method Adult male to adult female THY ABD WB I is distributed in the adult male phantoms at three different regions: thyroid (THY), abdominal region (ABD) and whole body (WB). The value based on the point source/target method at 0.3 m is included for realistic comparison behaviour of the TEDE per cumulated activity for the whole body source shown in Figure 6 is very similar to that of the abdomen source region as shown in Figure 5. The values for 10- and 15-y-old phantoms are very close to those for the adult target phantom. For the three types of source distributions, the MC-based values at a distance of 1 m are lower by a factor of 2.3 on average than the NRC value that would have been selected regardless of distance, age and source non-uniformity. As a target phantom is younger, TEDE per cumulated activity significantly decreases with a smaller source distribution (e.g. thyroid), especially at a shorter distance. It might be incorrect to assume that the point source method is always valid for the thyroid source region. TEDE per cumulated activity for lying position TEDE per cumulated activity (msv MBq 21 h 21 )in the simulation of the lying scenario is presented in Table 2 for the three source distributions: thyroid, abdomen and whole body. The value from the point source method at a distance of 0.3 m is higher than our values by a factor of 26, 29 and 23 for thyroid, abdomen and whole body region source, respectively. It is attributable from ignoring partial lateral irradiation from the adult male phantom in lying position and internal shielding between two phantoms. On this basis, a licensee can provide the patient with more specific instructions. CONCLUSIONS The MC-based calculations were performed with the revised ORNL paediatric and adult phantoms as a function of distance and different distributions of 131 I activity within the adult male phantom. Maximum releasable administered activities in accordance with the regulatory limit of 5 msv TEDE, and TEDE per cumulated activity were explicitly calculated by using the tissue-weighting factor of ICRP Publication 60 and the organ doses instead of relying on the exposure rate constant used in the point source/target method. The results of this study indicate that the overestimation of TEDE per cumulated activity based on the point source/target method is.2-fold. Therefore, licensees can release the adult male patient who has been administered higher activity and even further, the total cost of the overall procedure can be reduced because of shorter time of hospitalisation. The values of TEDE per cumulated activity obtained by the point source/target method in the scenario of lying are higher than the MC-based values by a factor of up to 29. TEDE per cumulated activity to the paediatric phantoms shows strong age (height)-dependencies, which reveal that dosimetry for children should be separately considered instead of using adult phantoms as a substitute. In conclusion, on the basis of the results of this study, a licensee may use less conservative patientspecific release criteria and provide the patient and the family members with more practical guidelines. Future studies will invoke the use of the paediatric and adult male and female hybrid phantoms generated by the University of Florida and National Cancer Institute, which are more realistic than the stylised phantoms in terms of organ structures as well as body contour. REFERENCES 1. USNRC. Criteria for the release of individuals administered radioactive materials NRC. Final rule U.S. Nuclear Regulatory Commission (1997). 2. USNRC. Consolidated Guidance About Materials Licensees: Program-Specific Guidance about Medical Use Licenses U.S. Nuclear Regulatory Commission (2002). 3. Protection N. C. o. R., Measurements. Precautions in the management of patients who have received therapeutic amounts of radionuclides: recommendations. National Council on Radiation Protection and Measurements (1970). 4. Siegel, J. A., Marcus, C. S. and Sparks, R. B. Calculating the absorbed dose from radioactive patients: Page 8 of 9
10 the line-source versus point-source model. J. Nucl. Med. 43, 1241 (2002). 5. Sparks, R. B., Siegel, J. A. and Wahl, R. L. The need for better methods to determine release criteria for patients administered radioactive material. Health Phys. 75, 385 (1998). 6. de Carvalho, A. B. Jr, Hunt, J., Silva, A. X. and Garcia, F. Use of a voxel phantom as a source and a second voxel phantom as a target to calculate effective doses in individuals exposed to patients treated with 131I. J. Nucl. Med. Technol. 37, (2009). 7. de Carvalho, A. B. Jr, Stabin, M. G., Siegel, J. A. and Hunt, J. Comparison of point, line and volume dose calculations for exposure to nuclear medicine therapy patients. Health Phys. 100, 185 (2011). 8. Juweid, M. E. Radioimmunotherapy of B-cell non- Hodgkin s lymphoma: from clinical trials to clinical practice. J. Nucl. Med. 43, 1507 (2002). 9. Han, E. Y., Bolch, W. and Eckerman, K. Revisions to the ORNL series of adult and pediatric computational phantoms for use with the MIRD schema. Health Phys. 90, (2006). TEDE CALCULATION BY MONTE CARLO 10. Cristy, M. and Eckerman, K. F. Specific absorbed fractions of energy at various ages from internal photon sources. ORNL/TM-8381 Vol Oak Ridge National Laboratory (1987). 11. Bolch, W. E., Eckerman, K. F., Sgouros, G. and Thomas, S. R. MIRD Pamphlet No. 21: a generalized schema for radiopharmaceutical dosimetry standardization of nomenclature. J.Nucl.Med.50, 477 (2009). 12. ICRP recommendations of the International Commission Radiological Protection. ICRP publication 60. International Commission on Radiological Protection (1991). 13. Brown, F. MCNP A General Monte Carlo N-Particle Transport Code, Version 5 Los Alamos National Laboratory. (2003). 14. Mountford, P., O doherty, M., Forge, N., Jeffries, A. and Coakley, A. Radiation dose rates from adult patients undergoing nuclear medicine investigations. Nucl. Med. Commun. 12, 767 (1991). 15. Parthasarathy, K. L. and Crawford, E. S. Treatment of thyroid carcinoma: emphasis on high-dose 131I outpatient therapy. J.Nucl.Med.Technol.30, (2002) Page 9 of 9
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