• Korean Journal of Clinical Laboratory Science
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• v.48 no.2
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• pp.158-167
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• 2016

The requirements for medical laboratories ISO 15189 is examined in organization and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Medical services are provided from the areas of resource management, and pre-examination, examination and post-examination processes. The main goal of ISO 15189 accreditation is to improve the quality of laboratory services provided for patients and clinical users not only through compliance with consensually developed and harmonized requirements but also by adopting the philosophy of continual improvement using the Plan-Do-Check-Act cycle. Laboratory quality should be evaluated and improved in all steps of the testing process as the state-of-the art indicates that the pre- and post-analytical phases are more vulnerable to errors than the intra-analytical phase. The Korea Laboratory Accreditation Scheme (KOLAS), a national accreditation body, provides medical laboratory accreditations for appropriate approaches to evaluating the competence of a medical laboratory in providing effective services to its customers and clinical users. Adoption of ISO 15189 in 2010s as a government policy has been delayed, and only 5 laboratories have been accredited to date in Korea. The medical laboratories should seek the adoption of ISO 15189 with a positive attitude for quality improvement and strengthening of international competitiveness.

• Radiation Oncology Journal
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• v.15 no.1
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• pp.1-10
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• 1997

Purpose : To evaluate the role of radiotherapy in the management of incompletely resected supratentorial low grade astrocytoma with the analysis of the survival, the Pattern of failure, and the prognostic variables affecting survival. Material and methods : Between January 1990 and December 1995, fifty-one patients with supratentorial low grade astrocytoma received radiotherapy after subtotal resection(16 patients) or stereotactic biopsy(35 patients) at Asan Medical Center, External radiotherapy was done by conventional fractionation with the total dose of 4820cGy to 6000cGy(median 5580cGy) and partial brain volume. The follow-up was done from 6 to 79 months(median 48 months) Result : Overall actuarial survival rate at 2 and 5 years were $83.4\%\;and\;54.8\%$, respectively. Progression free survival at 2 and 5 years were $67.4\%\;and\;48.7\%$, respectively The significant prognostic factors affecting overall survival rate were the performance status, 1 stage, histologic subtype, radiation field and radiation response. The major pattern of failure was local failure, such as Progressive disease and primary site recurrence in 23 patients $(45.1\%)$. Progression free survivors excluding 2 patients were physically and intellectually intact without major neurologic deficit. Conclusion : Although the follow-up period of this study was relatively short, overall actuarial and progression free survival rate were encouraging. Patients with good performance status, lower T stage, pilocytic subtype, patients treated with small radiation field and radiation responder showed better survival. As the local failure was the major pattern of failure, the various efforts to decrease the local failure is necessary.

• Progress in Medical Physics
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• v.23 no.4
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• pp.279-284
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• 2012

The X ray has been widely used in both diagnosis and treatment. Recently, a miniature X ray tube has been developed for radiotherapy. The miniature X ray tube is directly inserted into the body irradiated, so that X rays can be guided to a target at various incident angles according to collimator geometry and, thus, minimize patient dose. If such features of the miniature X ray tube can be applied to development of X ray imaging as well as radiation treatment, it is expected to open a new chapter in the field of diagnostic X ray. However, the miniature X ray tube requires an added filter and a collimator for diagnostic purpose because it was designed for radiotherapy. Therefore, a collimator and an added filter were manufactured for the miniature X ray tube, and mounted on. In this study, we evaluated beam characteristics of the miniature X ray tube for diagnostic X ray system and accuracy of measuring the HVL. We used the Si PIN Photodiode type Piranha detector (Piranha, RTI, Sweden) and estimated the HVL of the miniature X ray tube with added filter and without added filter. Through an another measurement using Al filter, we evaluated the accuracy of the HVL obtained from a direct measurement using the automatic HVL calculation function provided by the Piranha detector. As a result, the HVL of the miniature X ray tube was increased around 1.9 times with the added filter mounted on. So we demonstrated that the HVL was suitable for diagnostic X ray system. In the case that the added filter was not mounted on, the HVL obtained from use of the automatic HVL calculation function provided by Piranha detector was 50% higher than the HVL estimated using Al filter. Therefore, the HVL automatic measurement from the Piranha detector cannot be used for the HVL calculation. However, when the added filter was mounted on, the HVL automatic measurement value using the Piranha detector was approximately 15% lower than the estimated value using Al filter. It implies that the HVL automatic measurement can be used to estimate the HVL of the miniature X ray tube with the added filter mounted on without a more complicated measurement method using Al filter. It is expected that the automatic HVL measurement provided by the Piranha detector enables to make kV-X ray characterization easier.

• Progress in Medical Physics
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• v.25 no.4
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• pp.271-280
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• 2014

Recently, digital breast tomosynthesis (DBT) has been investigated to overcome the limitation of conventional mammography for overlapping anatomical structures and high patient dose with cone-beam computed tomography (CBCT). However incomplete sampling due to limited angle leads to interference on the neighboring slices. Many studies have investigated to reduce artifacts such as interference. Moreover, appropriate filters for tomosynthesis have been researched to solve artifacts resulted from incomplete sampling. The primary purpose of this study is finding appropriate filter scheme with FBP reconstruction for DBT system to reduce artifacts. In this study, we investigated characteristics of various filter schemes with simulation and prototype digital breast tomosynthesis under same acquisition parameters and conditions. We evaluated artifacts and noise with profiles and COV (coefficinet of variation) to study characteristic of filter. As a result, the noise with parameter 0.25 of Spectral filter reduced by 10% in comparison to that with only Ramp-lak filter. Because unbalance of information reduced with decreasing B of Slice thickness filter, artifacts caused by incomplete sampling reduced. In conclusion, we confirmed basic characteristics of filter operations and improvement of image quality by appropriate filter scheme. The results of this study can be utilized as base in research and development of DBT system by providing information that is about noise and artifacts depend on various filter schemes.

• Journal of radiological science and technology
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• v.36 no.1
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• pp.1-10
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• 2013

IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as $3^{rd}$ edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 $3^{rd}$ Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 $3^{rd}$ Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.

• Radiation Oncology Journal
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• v.24 no.1
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• pp.67-76
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• 2006

Purpose: Oral mucositis is a common toxicity of radiation or chemotherapy, which is used a treatment for head and neck cancer. We investigated effects of recombinant human epidermal growth factor (rhEGF) on radiation-induced oral mucositis in rat model. Materials and Methods: Spraque-Dawley rats (7 per group) exposed to a single dose of 25 Gy (day 0) on their head, except for one group, were randomly divided into un-treated, vehicle-treated, and two rhEGF-treated groups. Rats were topically applied with rhEGF (15 or $30{\mu}g/oral$ cavity/day) or vehicle to their oral mucosa. Survival rate of rats, weight changes, and food intakes were examined from day 0 to 18 after radiation. Histology study was performed from oral mucosa of rats at day 7 and 18 after radiation. Results: rhEGF-treated groups (15 or $30{\mu}g/oral$) showed all survival rate 33%, whereas un-treated and vehicle-treated groups showed all survival rate 0% at the end of experiment. rhEGF-treated groups statistically had less weight loss compared to vehicle-treated group from day 2 to 7 after radiation. Food intake of rats with rhEGF treatment turned to increase at day 14 after radiation. At 7 day after radiation, un-treated and vehicle-treated groups showed severe pseudomembraneous or ulcerative oral mucositis. On the other hand, rhEGF-treated groups had no more than cellular swelling and degeneration of epidermal cells in oral mucosa of rats. Conclusion: These results suggest that rhEGF has significantly positive effects on radiation-induced oral mucositis in rats. rhEGF display a therapeutic potential on a clinical level.

• Radiation Oncology Journal
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• v.22 no.4
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• pp.247-253
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• 2004

Purpose: Hypopharyngeal cancer is diagnosed at the advanced stage in most cases, which the prognosis known to be poor. Thus, the efficacy of induction chemotherapy followed by radiotherapy, with regards to the response and survival rate for stage IV hypopharyngeal cancer patients, was examined. Materials and Methods: From July 1998 to February 2000, 18 cases were diagnosedas AJCC stage IV hypopharyngeal cancer without distant metastasis. These patients were treated with induction chemotherapy followed by radiotherapy, and the results retrospectively analyzed. The regimen of the induction chemotherapy was the 5-FU and cisplatincombination, at 3-week intervals for, 2 cycles. The total radiation dose for the primary lesion and metastatic lymph nodes was $68.4\~72.0$Gy (median: 70.2 Gy). Results: The: The median follow up period was 28 months, ranging from 7 to 99 months. The 3-year overall survival and disease-free survival rate were 41.7 and $31.1\%$, respectively. In 6 cases ($33.3\%$), conservation of the larynx for over 3 years was possible. After the induction chemotherapy there were 16 partial responses ($88.8\%$), 1 complete response and 1 with no response ($5.6\%$ each), therefore, 17 of the 18 cases ($94.6\%$) showed responses. After the completion of the induction chemotherapy and radiotherapy, a complete response was noted in 13 cases ($72.2\%$), a partial response in 5 ($27.8\%$), with an overall response rate of $100\%$. In the analysis of the prognostic factors influencing the survival rate, the 3-year and disease-free survival rates for the complete and partial response groups were 43.1, and $20.0\%$, and 39.6, and $20.0\%$, respectively (p=0.0003, p=0.002). Only the final response after treatment completion was statistically significant. Conclusion: For stage IV hypopharyngeal cancer, induction chemotherapy followed by radiotherapy was an effective treatment, with no severe side effects.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• Journal of the Korean Society of Radiology
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• v.17 no.4
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• pp.489-495
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• 2023

Radiation shielding facilities are constructed in locations where diagnostic radiation generators are installed, with the aim of preventing exposure for patients and radiation workers. The purpose of this study is seek to compare and validate the trend of attenuation thickness of lead, the primary material in these radiation shielding facilities, at different maximum tube voltages by Monte Carlo simulations and measurement. We employed the Monte Carlo N-Particle 6 simulation code. Within this simulation, we set a lead shielding arrangement, where the distance between the source and the lead sheet was set at 100 cm and the field of view was set at 10 × 10 cm². Additionally, we varied the tube voltages to encompass 80, 100, 120, and 140 kVp. We calculated energy spectra for each respective tube voltage and applied them in the simulations. Lead thicknesses corresponding to attenuation rates of 50, 70, 90, and 95% were determined for tube voltages of 80, 100, 120, and 140 kVp. For 80 kVp, the calculated thicknesses for these attenuation rates were 0.03, 0.08, 0.21, and 0.33 mm, respectively. For 100 kVp, the values were 0.05, 0.12, 0.30, and 0.50 mm. Similarly, for 120 kVp, they were 0.06, 0.14, 0.38, and 0.56 mm. Lastly, at 140 kVp, the corresponding thicknesses were 0.08, 0.16, 0.42, and 0.61 mm. Measurements were conducted to validate the calculated lead thicknesses. The radiation generator employed was the GE Healthcare Discovery XR 656, and the dosimeter used was the IBA MagicMax. The experimental results showed that at 80 kVp, the attenuation rates for different thicknesses were 43.56, 70.33, 89.85, and 93.05%, respectively. Similarly, at 100 kVp, the rates were 52.49, 72.26, 86.31, and 92.17%. For 120 kVp, the attenuation rates were 48.26, 71.18, 87.30, and 91.56%. Lastly, at 140 kVp, they were measured 50.45, 68.75, 89.95, and 91.65%. Upon comparing the simulation and experimental results, it was confirmed that the differences between the two values were within an average of approximately 3%. These research findings serve to validate the reliability of Monte Carlo simulations and could be employed as fundamental data for future radiation shielding facility construction.

• Journal of the Korean Society of Radiology
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• v.83 no.6
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• pp.1327-1341
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• 2022

Purpose To evaluate the pattern of use and the perception of digital breast tomosynthesis (DBT) among Korean breast radiologists. Materials and Methods From March 22 to 29, 2021, an online survey comprising 27 questions was sent to members of the Korean Society of Breast Imaging. Questions related to practice characteristics, utilization and perception of DBT, and research interests. Results were analyzed based on factors using logistic regression. Results Overall, 120 of 257 members responded to the survey (response rate, 46.7%), 67 (55.8%) of whom reported using DBT. The overall satisfaction with DBT was 3.31 (1-5 scale). The most-cited DBT advantages were decreased recall rate (55.8%), increased lesion conspicuity (48.3%), and increased cancer detection (45.8%). The most-cited DBT disadvantages were extra cost for patients (46.7%), insufficient calcification characterization (43.3%), insufficient improvement in diagnostic performance (39.2%), and radiation dose (35.8%). Radiologists reported increased storage requirements and interpretation time for barriers to implementing DBT. Conclusion Further improvement of DBT techniques reflecting feedback from the user's perspective will help increase the acceptance of DBT in Korea.