• Title/Summary/Keyword: Dose Estimation

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Maximum tolerated dose estimation by Biased coin design and stopping rule in Phase I clinical trial (제 1상 임상시험에서 Biased Coin Design과 멈춤규칙을 이용한 MTD 추정법)

  • Jeon, Soyoung;Kim, Dongjae
    • The Korean Journal of Applied Statistics
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    • v.33 no.2
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    • pp.137-145
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    • 2020
  • Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

Accuracy of Dose Estimation in High Dose Rate Intracavitary Radiotherapy of Carcinoma of the Uterine Cervix (자궁경부암 고선량율 강내치료의 치료선량 정확도에 관한 연구)

  • Huh, Seung-Jae;Ha, Sung-Whan;Chai, Kyu-Young
    • Radiation Oncology Journal
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    • v.5 no.2
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    • pp.137-140
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    • 1987
  • In brachytherapy of uterine conical cancer using a high dose rate remote afterloading system, it is of prime importance to deliver a accurate dose in each fractionated treatment by minimizing the difference between the pre-treatment planned and post-treatment calculated doses. The post-treatment calculated point A dose was not much different from the pretreatment planned dose (500 cGy). The $average{\pm}standard$ deviation was $500\pm18cGy$ and 84 percent of 82 intracavitary radiotherapy was within the range of $500\pm25cGy$.

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Estimating dose-response curves using splines: a nonparametric Bayesian knot selection method

  • Lee, Jiwon;Kim, Yongku;Kim, Young Min
    • Communications for Statistical Applications and Methods
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    • v.29 no.3
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    • pp.287-299
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    • 2022
  • In radiation epidemiology, the excess relative risk (ERR) model is used to determine the dose-response relationship. In general, the dose-response relationship for the ERR model is assumed to be linear, linear-quadratic, linear-threshold, quadratic, and so on. However, since none of these functions dominate other functions for expressing the dose-response relationship, a Bayesian semiparametric method using splines has recently been proposed. Thus, we improve the Bayesian semiparametric method for the selection of the tuning parameters for splines as the number and location of knots using a Bayesian knot selection method. Equally spaced knots cannot capture the characteristic of radiation exposed dose distribution which is highly skewed in general. Therefore, we propose a nonparametric Bayesian knot selection method based on a Dirichlet process mixture model. Inference of the spline coefficients after obtaining the number and location of knots is performed in the Bayesian framework. We apply this approach to the life span study cohort data from the radiation effects research foundation in Japan, and the results illustrate that the proposed method provides competitive curve estimates for the dose-response curve and relatively stable credible intervals for the curve.

Validation of a Model for Estimating Individual External Dose Based on Ambient Dose Equivalent and Life Patterns

  • Sato, Rina;Yoshimura, Kazuya;Sanada, Yukihisa;Sato, Tetsuro
    • Journal of Radiation Protection and Research
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    • v.47 no.2
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    • pp.77-85
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    • 2022
  • Background: After the Fukushima Daiichi Nuclear Power Station (FDNPS) accident, a model was developed to estimate the external exposure doses for residents who were expected to return to their homes after evacuation orders were lifted. However, the model's accuracy and uncertainties in parameters used to estimate external doses have not been evaluated. Materials and Methods: The model estimates effective doses based on the integrated ambient dose equivalent (H*(10)) and life patterns, considering a dose reduction factor to estimate the indoor H*(10) and a conversion factor from H*(10) to the effective dose. Because personal dose equivalent (Hp(10)) has been reported to agree well with the effective dose after the FDNPS accident, this study validates the model's accuracy by comparing the estimated effective doses with Hp(10). The Hp(10) and life pattern data were collected for 36 adult participants who lived or worked near the FDNPS in 2019. Results and Discussion: The estimated effective doses correlated significantly with Hp(10); however, the estimated effective doses were lower than Hp(10) for indoor sites. A comparison with the measured indoor H*(10) showed that the estimated indoor H*(10) was not underestimated. However, the Hp(10) to H*(10) ratio indoors, which corresponds to the practical conversion factor from H*(10) to the effective dose, was significantly larger than the same ratio outdoors, meaning that the conversion factor of 0.6 is not appropriate for indoors due to the changes in irradiation geometry and gamma spectra. This could have led to a lower effective dose than Hp(10). Conclusion: The estimated effective doses correlated significantly with Hp(10), demonstrating the model's applicability for effective dose estimation. However, the lower value of the effective dose indoors could be because the conversion factor did not reflect the actual environment.

Estimation of Maximal Tolerated Dose in Sequential Phase I Clinical Trials

  • Park, In-Hye;Song, Hae-Hiang
    • Communications for Statistical Applications and Methods
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    • v.6 no.2
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    • pp.543-564
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    • 1999
  • The principal aim of a sequential phase I clinical trial in which the toxicity reponses of a group of patient(s) determine the dose level of the next patient(s) group is to estimate the maximal tolerated dose(MTD) of a new drug, In this paper we compared with a simulation study the performance of the MTD estimates that are determined by a stopping rule in a design and also those that are determined by analyzing the data after a clinical trial is terminated. To the latter belong the mean median mode and maximum likelihood estimates. For the Standard Methods the stopping rule MTD is quite inefficient but the median MTD has a best efficiency and is robust with respect to the three different toxicity curves. The problem of non-convergence of MLE MTD is severe. A more improved MTD estimate is produced by combining the advantages of the various MTD estimates and its efficiency is better than the single median MTD estimate especially for the toxicity curve of an unlucky choice of dose levels. The simulation results suggest that simple types of phase I designs can be combined with relatively standard analytic techniques to provide a more efficient MTD estimate.

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APPLICATION OF WHOLE BODY COUNTER TO NEUTRON DOSE ASSESSMENT IN CRITICALITY ACCIDENTS

  • Kurihara, O.;Tsujimura, N.;Takasaki, K.;Momose, T.;Maruo, Y.
    • Journal of Radiation Protection and Research
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    • v.26 no.3
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    • pp.249-253
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    • 2001
  • Neutron dose assessment in criticality accidents using Whole Body Counter (WBC) was proved to be an effective method as rapid neutron dose estimation at the JCO criticality accident in Tokai-mura. The 1.36MeV gamma-ray of $^{24}Na$ in a body can be detected easily by a germanium detector. The Minimum Detectable Activity (MDA) of $^{24}Na$ is approximately 50Bq for 10miniute measurement by the germanium-type whole body counter at JNC Tokai Works. Neutron energy spectra at the typical shielding conditions in criticality accidents were calculated and the conversion factor, whole body activity-to-organ mass weighted neutron absorbed dose, corresponding to each condition were determined. The conversion factor for uncollied fission spectrum is 7.7 $[(Bq^{24}Na/g^{23}Na)/mGy]$.

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Dose Estimation of Patient by X-ray Positioning in Particle Cancer Therapy

  • Hirai, Masaaki;Nishizawa, Kanae;Shibayama, Kouichi;Kanai, Tatsuaki
    • Proceedings of the Korean Society of Medical Physics Conference
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    • 2002.09a
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    • pp.206-207
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    • 2002
  • The effective dose due to the X-Ray radiography in the patient positioning for the heavy ion radiotherapy was measured on three regions, chest, upper-abdomen and pelvis. All the radiographic systems and the conditions used in the measurements were same as the clinical trial being performed in National Institute of Radiological Sciences, Japan. The organ or tissue for measurements was selected by following ICRP60$^1$ and the effective dose was calculated from measured organ doses and the surface dose.

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Review on controllers with a time delay estimation (시간지연추정제어기에 관한 리뷰)

  • Lee H.J.;Yoon J.S.
    • Proceedings of the Korean Society of Precision Engineering Conference
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    • 2005.06a
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    • pp.1120-1124
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    • 2005
  • We reviewed controllers with a time delay estimation in this paper. Time delay control (TDC) and sliding mode control (SMC) are well known robust control schemes. Basically, the TDC has a main characteristic called a time delay estimation from which we can estimate the total uncertainty of a system. . The TDC causes the stick-slip in the case of systems with a friction. The so-called TDCSA which are short for TDC with switching action was developed to reduce the stick-slip. The TDC has the additional switching action term in the TDC structure. In the other hand, the SMC dose not have a time delay estimation but instead it can estimate the system uncertainty through the switching action. The SMC has a difficulty to estimate the total uncertainty of a system because it does not have a time delay estimation. In order to solve the difficulty, some control schemes were developed. Among them, we need to focus our attention on two control schemes: SMCPE and SMCTE, which are short for sliding mode control with a perturbation estimation and sliding mode control with a time delay estimation, respectively. In this paper, we analyzed and compared the characteristic of above three controllers. Even though the motives for the development of three control schemes are different, three control schemes have much in common in terms of their controller structures.

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Estimation of the Number of Salmonellosis Using Microbial Risk Assessment Methodology (미생물 위해성 평가 방법을 이용한 살모넬라 발생수 추정)

  • 최은영;박경진
    • The Korean Journal of Community Living Science
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    • v.15 no.2
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    • pp.167-177
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    • 2004
  • The number of foodborne salmonellosis was estimated by using microbial risk assessment(MRA) methodology and the possibility of application was studied through comparison with previous results. The contamination levels of Salmonella sp. were estimated by using published domestic studies(1997∼2000) and monitoring data (1999∼2001) from food-safety related institutes. Data on food consumption came from the 2001 National Health and Nutrition Survey, and dose-response models from studies in other countries. Simulation results showed that there were 753,368 cases of salmonellosis in Korea in 1 year, which is about 115 times that reported in previous years and lower than the WHO's estimation increase. From these results, microbial risk assessment is likely to be available for estimation of the number of foodborne illnesses and determination of the order of priority in food-safety management. Butthe verification methods are not established and most of the data on contamination levels of foodborne bacteria, food consumption, and dose-response relationships have not been established. In addition, the actual conditions of circulation, storage and cooking must be studied further.

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Estimating Organ Doses from Pediatric Cerebral Computed Tomography Using the WAZA-ARI Web-Based Calculator

  • Etani, Reo;Yoshitake, Takayasu;Kai, Michiaki
    • Journal of Radiation Protection and Research
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    • v.46 no.1
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    • pp.1-7
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    • 2021
  • Background: The use of computed tomography (CT) device has increased in the past few decades in Japan. Dose optimization is strongly required in pediatric CT examinations, since there is concern that an unreasonably excessive medical radiation exposure might increase the risk of brain cancer and leukemia. To accelerate the process of dose optimization, continual assessment of the dose levels in actual hospitals and medical facilities is necessary. This study presents organ dose estimation using pediatric cerebral CT scans in the Kyushu region, Japan in 2012 and the web-based calculator, WAZA-ARI (https://waza-ari.nirs.qst.go.jp). Materials and Methods: We collected actual patient information and CT scan parameters from hospitals and medical facilities with more than 200 beds that perform pediatric CT in the Kyushu region, Japan through a questionnaire survey. To estimate the actual organ dose (brain dose, bone marrow dose, thyroid dose, lens dose), we divided the pediatric population into five age groups (0, 1, 5, 10, 15) based on body size, and inputted CT scan parameters into WAZA-ARI. Results and Discussion: Organ doses for each age group were obtained using WAZA-ARI. The brain dose, thyroid dose, and lens dose were the highest in the Age 0 group among the age groups, and the bone marrow and thyroid doses tended to decrease with increasing age groups. All organ doses showed differences among facilities, and this tendency was remarkable in the young group, especially in the Age 0 group. This study confirmed a difference of more than 10-fold in organ doses depending on the facility and CT scan parameters, even when the same CT device was used in the same age group. Conclusion: This study indicated that organ doses varied widely by age group, and also suggested that CT scan parameters are not optimized for children in some hospitals and medical facilities.