• Title/Summary/Keyword: patient variation

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The Validation of a Commercial Testosterone RIA Test Kits (Testosterone RIA 검사 kit 별 유효성 비교평가)

  • Ryu, Hwa-jin;Shin, Seon-yeong;Cho, Seong-uk
    • The Korean Journal of Nuclear Medicine Technology
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    • v.26 no.1
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    • pp.38-41
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    • 2022
  • Purpose Testosterone is a steroid hormone synthesized by the Leydig cells of the testes in men, and by the adrenal cortex and ovaries in women. Testosterone production is regulated by luteinzing hormone secreted by the anterior pituitary gland. In this experiment, the effectiveness of testosterone radioimmunoassay (RIA) kits produced by three companies was evaluated and compared in case the production of testosterone kits was stopped or supply problems occurred. Materials and Methods In October 2021, samples were collected from the patients (n=49) who requested the testosterone RIA test. The experiment was conducted by dividing the patient's sample into low concentration (1.0 ng/mL or less), medium concentration (2.0-4.0 ng/mL) and high concentration (6.0 ng/mL or more). The Testosterone RIA test compared and evaluated the validity of Company A kits used in this hospital and those of Company B and C used in other hospitals. The precision, sensitivity, recovery, linearity and correlation were evaluated for each kit. The testosterone RIA test was carried out in accordance with the insert kit manual for each manufacturer. Results As a result of measuring the precision of the intra assay, the Coefficient of Variation (CV) value of the company A kit was high at 11.4% only in the low concentration sample, and in the case of the company B and C kits, the CV value was less than 10% at low, medium, and high concentrations. In the inter-assay precision measurement, the CV value was less than 15% in both A and C kits, but in the case of the B kit, the CV value exceeded 15% at low and medium concentrations. Sensitivity was 0.13 ng/mL for company A, 0.01 ng/mL for company B, and 0.01 ng/mL for company C, and the linearity of all three kits showed excellent linearity. In the case of recovery rate, all of the A, B, and C company kits showed results that were out of 90-110%. In the case of correlation test, when compared with the company A kit currently use in here, the correlation coefficient (R2) value for the company B kit was 0.9508, and for the company C kit was 0.9352 Conclusion As a result, there was a slight difference in precision at the low concentration sample. The correlation test showed an excellent correlation coefficient. However, it was difficult to secure samples of various concentrations because there were not many tests of testosterone requested at this hospital. So, additional experiments should be carried out by acquiring samples of various concentrations on each laboratory later.

Radioimmunoassay Reagent Survey and Evaluation (검사별 radioimmunoassay시약 조사 및 비교실험)

  • Kim, Ji-Na;An, Jae-seok;Jeon, Young-woo;Yoon, Sang-hyuk;Kim, Yoon-cheol
    • The Korean Journal of Nuclear Medicine Technology
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    • v.25 no.1
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    • pp.34-40
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    • 2021
  • Purpose If a new test is introduced or reagents are changed in the laboratory of a medical institution, the characteristics of the test should be analyzed according to the procedure and the assessment of reagents should be made. However, several necessary conditions must be met to perform all required comparative evaluations, first enough samples should be prepared for each test, and secondly, various reagents applicable to the comparative evaluations must be supplied. Even if enough comparative evaluations have been done, there is a limit to the fact that the data variation for the new reagent represents the overall patient data variation, The fact puts a burden on the laboratory to the change the reagent. Due to these various difficulties, reagent changes in the laboratory are limited. In order to introduce a competitive bid, the institute conducted a full investigation of Radioimmunoassay(RIA) reagents for each test and established the range of reagents available in the laboratory through comparative evaluations. We wanted to share this process. Materials and Methods There are 20 items of tests conducted in our laboratory except for consignment tests. For each test, RIA reagents that can be used were fully investigated with the reference to external quality control report. and the manuals for each reagent were obtained. Each reagent was checked for the manual to check the test method, Incubation time, sample volume needed for the test. After that, the primary selection was made according to whether it was available in this laboratory. The primary selected reagents were supplied with 2kits based on 100tests, and the data correlation test, sensitivity measurement, recovery rate measurement, and dilution test were conducted. The secondary selection was performed according to the results of the comparative evaluation. The reagents that passed the primary and secondary selections were submitted to the competitive bidding list. In the case of reagent is designated as a singular, we submitted a explanatory statement with the data obtained during the primary and secondary selection processes. Results Excluded from the primary selection was the case where TAT was expected to be delayed at the moment, and it was impossible to apply to our equipment due to the large volume of reagents used during the test. In the primary selection, there were five items which only one reagent was available.(squamous cell carcinoma Ag(SCC Ag), β-human chorionic gonadotropin(β-HCG), vitamin B12, folate, free testosterone), two reagents were available(CA19-9, CA125, CA72-4, ferritin, thyroglobulin antibody(TG Ab), microsomal antibody(Mic Ab), thyroid stimulating hormone-receptor-antibody(TSH-R-Ab), calcitonin), three reagents were available (triiodothyronine(T3), Tree T3, Free T4, TSH, intact parathyroid hormone(intact PTH)) and four reagents were available are carcinoembryonic antigen(CEA), TG. In the secondary selection, there were eight items which only one reagent was available.(ferritin, TG, CA19-9, SCC, β-HCG, vitaminB12, folate, free testosterone), two reagents were available(TG Ab, Mic Ab, TSH-R-Ab, CA125, CA72-4, intact PTH, calcitonin), three reagents were available(T3, Tree T3, Free T4, TSH, CEA). Reasons excluded from the secondary selection were the lack of reagent supply for comparative evaluations, the problems with data reproducibility, and the inability to accept data variations. The most problematic part of comparative evaluations was sample collection. It didn't matter if the number of samples requested was large and the capacity needed for the test was small. It was difficult to collect various concentration samples in the case of a small number of tests(100 cases per month or less), and it was difficult to conduct a recovery rate test in the case of a relatively large volume of samples required for a single test(more than 100 uL). In addition, the lack of dilution solution or standard zero material for sensitivity measurement or dilution tests was one of the problems. Conclusion Comparative evaluation for changing test reagents require appropriate preparation time to collect diverse and sufficient samples. In addition, setting the total sample volume and reagent volume range required for comparative evaluations, depending on the sample volume and reagent volume required for one test, will reduce the burden of sample collection and planning for each comparative evaluation.

An accuracy analysis of Cyberknife tumor tracking radiotherapy according to unpredictable change of respiration (예측 불가능한 호흡 변화에 따른 사이버나이프 종양 추적 방사선 치료의 정확도 분석)

  • Seo, jung min;Lee, chang yeol;Huh, hyun do;Kim, wan sun
    • The Journal of Korean Society for Radiation Therapy
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    • v.27 no.2
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    • pp.157-166
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    • 2015
  • Purpose : Cyber-Knife tumor tracking system, based on the correlation relationship between the position of a tumor which moves in response to the real time respiratory cycle signal and respiration was obtained by the LED marker attached to the outside of the patient, the location of the tumor to predict in advance, the movement of the tumor in synchronization with the therapeutic device to track real-time tumor, is a system for treating. The purpose of this study, in the cyber knife tumor tracking radiation therapy, trying to evaluate the accuracy of tumor tracking radiation therapy system due to the change in the form of unpredictable sudden breathing due to cough and sleep. Materials and Methods : Breathing Log files that were used in the study, based on the Respiratory gating radiotherapy and Cyber-knife tracking radiosurgery breathing Log files of patients who received herein, measured using the Log files in the form of a Sinusoidal pattern and Sudden change pattern. it has been reconstituted as possible. Enter the reconstructed respiratory Log file cyber knife dynamic chest Phantom, so that it is possible to implement a motion due to respiration, add manufacturing the driving apparatus of the existing dynamic chest Phantom, Phantom the form of respiration we have developed a program that can be applied to. Movement of the phantom inside the target (Ball cube target) was driven by the displacement of three sizes of according to the size of the respiratory vertical (Superior-Inferior) direction to the 5 mm, 10 mm, 20 mm. Insert crosses two EBT3 films in phantom inside the target in response to changes in the target movement, the End-to-End (E2E) test provided in Cyber-Knife manufacturer depending on the form of the breathing five times each. It was determined by carrying. Accuracy of tumor tracking system is indicated by the target error by analyzing the inserted film, additional E2E test is analyzed by measuring the correlation error while being advanced. Results : If the target error is a sine curve breathing form, the size of the target of the movement is in response to the 5 mm, 10 mm, 20 mm, respectively, of the average $1.14{\pm}0.13mm$, $1.05{\pm}0.20mm$, with $2.37{\pm}0.17mm$, suddenly for it is variations in breathing, respective average $1.87{\pm}0.19mm$, $2.15{\pm}0.21mm$, and analyzed with $2.44{\pm}0.26mm$. If the correlation error can be defined by the length of the displacement vector in the target track is a sinusoidal breathing mode, the size of the target of the movement in response to 5 mm, 10 mm, 20 mm, respective average $0.84{\pm}0.01mm$, $0.70{\pm}0.13mm$, with $1.63{\pm}0.10mm$, if it is a variant of sudden breathing respective average $0.97{\pm}0.06mm$, $1.44{\pm}0.11mm$, and analyzed with $1.98{\pm}0.10mm$. The larger the correlation error values in both the both the respiratory form, the target error value is large. If the motion size of the target of the sine curve breathing form is greater than or equal to 20 mm, was measured at 1.5 mm or more is a recommendation value of both cyber knife manufacturer of both error value. Conclusion : There is a tendency that the correlation error value between about target error value magnitude of the target motion is large is increased, the error value becomes large in variation of rapid respiration than breathing the form of a sine curve. The more the shape of the breathing large movements regular shape of sine curves target accuracy of the tumor tracking system can be judged to be reduced. Using the algorithm of Cyber-Knife tumor tracking system, when there is a change in the sudden unpredictable respiratory due patient coughing during treatment enforcement is to stop the treatment, it is assumed to carry out the internal target validation process again, it is necessary to readjust the form of respiration. Patients under treatment is determined to be able to improve the treatment of accuracy to induce the observed form of regular breathing and put like to see the goggles monitor capable of the respiratory form of the person.

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Development of Conformal Radiotherapy with Respiratory Gate Device (호흡주기에 따른 방사선입체조형치료법의 개발)

  • Chu Sung Sil;Cho Kwang Hwan;Lee Chang Geol;Suh Chang Ok
    • Radiation Oncology Journal
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    • v.20 no.1
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    • pp.41-52
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    • 2002
  • Purpose : 3D conformal radiotherapy, the optimum dose delivered to the tumor and provided the risk of normal tissue unless marginal miss, was restricted by organ motion. For tumors in the thorax and abdomen, the planning target volume (PTV) is decided including the margin for movement of tumor volumes during treatment due to patients breathing. We designed the respiratory gating radiotherapy device (RGRD) for using during CT simulation, dose planning and beam delivery at identical breathing period conditions. Using RGRD, reducing the treatment margin for organ (thorax or abdomen) motion due to breathing and improve dose distribution for 3D conformal radiotherapy. Materials and Methods : The internal organ motion data for lung cancer patients were obtained by examining the diaphragm in the supine position to find the position dependency. We made a respiratory gating radiotherapy device (RGRD) that is composed of a strip band, drug sensor, micro switch, and a connected on-off switch in a LINAC control box. During same breathing period by RGRD, spiral CT scan, virtual simulation, and 3D dose planing for lung cancer patients were peformed, without an extended PTV margin for free breathing, and then the dose was delivered at the same positions. We calculated effective volumes and normal tissue complication probabilities (NTCP) using dose volume histograms for normal lung, and analyzed changes in doses associated with selected NTCP levels and tumor control probabilities (TCP) at these new dose levels. The effects of 3D conformal radiotherapy by RGRD were evaluated with DVH (Dose Volume Histogram), TCP, NTCP and dose statistics. Results : The average movement of a diaphragm was 1.5 cm in the supine position when patients breathed freely. Depending on the location of the tumor, the magnitude of the PTV margin needs to be extended from 1 cm to 3 cm, which can greatly increase normal tissue irradiation, and hence, results in increase of the normal tissue complications probabiliy. Simple and precise RGRD is very easy to setup on patients and is sensitive to length variation (+2 mm), it also delivers on-off information to patients and the LINAC machine. We evaluated the treatment plans of patients who had received conformal partial organ lung irradiation for the treatment of thorax malignancies. Using RGRD, the PTV margin by free breathing can be reduced about 2 cm for moving organs by breathing. TCP values are almost the same values $(4\~5\%\;increased)$ for lung cancer regardless of increasing the PTV margin to 2.0 cm but NTCP values are rapidly increased $(50\~70\%\;increased)$ for upon extending PTV margins by 2.0 cm. Conclusion : Internal organ motion due to breathing can be reduced effectively using our simple RGRD. This method can be used in clinical treatments to reduce organ motion induced margin, thereby reducing normal tissue irradiation. Using treatment planning software, the dose to normal tissues was analyzed by comparing dose statistics with and without RGRD. Potential benefits of radiotherapy derived from reduction or elimination of planning target volume (PTV) margins associated with patient breathing through the evaluation of the lung cancer patients treated with 3D conformal radiotherapy.

A STUDY ON THE TEMPERATURE CHANGES OF BONE TISSUES DURING IMPLANT SITE PREPARATION (임플랜트 식립부위 형성시 골조직의 온도변화에 관한 연구)

  • Kim Pyung-Il;Kim Yung-Soo;Jang Kyung-Soo;Kim Chang-Whe
    • The Journal of Korean Academy of Prosthodontics
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    • v.40 no.1
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    • pp.1-17
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    • 2002
  • The purpose of this study is to examine the possibility of thermal injury to bone tissues during an implant site preparation under the same condition as a typical clinical practice of $Br{\aa}nemark$ implant system. All the burs for $Br{\aa}nemark$ implant system were studied except the round bur The experiments involved 880 drilling cases : 50 cases for each of the 5 steps of NP, 5 steps of RP, and 7 steps of WP, all including srew tap, and 30 cases of 2mm twist drill. For precision drilling, a precision handpiece restraining system was developed (Eungyong Machinery Co., Korea). The system kept the drill parallel to the drilling path and allowed horizontal adjustment of the drill with as little as $1{\mu}m$ increment. The thermocouple insertion hole. that is 0.9mm in diameter and 8mm in depth, was prepared 0.2mm away from the tapping bur the last drilling step. The temperatures due to countersink, pilot drill, and other drills were measured at the surface of the bone, at the depths of 4mm and 8mm respectively. Countersink drilling temperature was measured by attaching the tip of a thermocouple at the rim of the countersink. To assure temperature measurement at the desired depths, 'bent-thermocouples' with their tips of 4 and 8mm bent at $120^{\circ}$ were used. The profiles of temperature variation were recorded continuously at one second interval using a thermometer with memory function (Fluke Co. U.S.A.) and 0.7mm thermocouples (Omega Co., U.S.A.). To simulate typical clinical conditions, 35mm square samples of bovine scapular bone were utilized. The samples were approximately 20mm thick with the cortical thickness on the drilling side ranging from 1 to 2mm. A sample was placed in a container of saline solution so that its lower half is submerged into the solution and the upper half exposed to the room air, which averaged $24.9^{\circ}C$. The temperature of the saline solution was maintained at $36.5^{\circ}C$ using an electric heater (J. O Tech Co., Korea). This experimental condition was similar to that of a patient s opened mouth. The study revealed that a 2mm twist drill required greatest attention. As a guide drill, a twist drill is required to bore through a 'virgin bone,' rather than merely enlarging an already drilled hole as is the case with other drills. This typically generates greater amount of heat. Furthermore, one tends to apply a greater pressure to overcome drilling difficulty, thus producing even greater amount heat. 150 experiments were conducted for 2mm twist drill. For 140 cases, drill pressure of 750g was sufficient, and 10 cases required additional 500 or 100g of drilling pressure. In case of the former. 3 of the 140 cases produced the temperature greater than $47^{\circ}C$, the threshold temperature of degeneration of bone tissue (1983. Eriksson et al.) which is also the reference temperature in this study. In each of the 10 cases requiring extra pressure, the temperature exceeded the reference temperature. More significantly, a surge of heat was observed in each of these cases This observations led to addtional 20 drilling experiments on dense bones. For 10 of these cases, the pressure of 1,250g was applied. For the other 10, 1.750g were applied. In each of these cases, it was also observed that the temperature rose abruptly far above the thresh old temperature of $47^{\circ}C$, sometimes even to 70 or $80^{\circ}C$. It was also observed that the increased drilling pressure influenced the shortening of drilling time more than the rise of drilling temperature. This suggests the desirability of clinically reconsidering application of extra pressures to prevent possible injury to bone tissues. An analysis of these two extra pressure groups of 1,250g and 1,750g revealed that the t-statistics for reduced amount of drilling time due to extra pressure and increased peak temperature due to the same were 10.80 and 2.08 respectively suggesting that drilling time was more influenced than temperature. All the subsequent drillings after the drilling with a 2mm twist drill did not produce excessive heat, i.e. the heat generation is at the same or below the body temperature level. Some of screw tap, pilot, and countersink showed negative correlation coefficients between the generated heat and the drilling time. indicating the more the drilling time, the lower the temperature. The study also revealed that the drilling time was increased as a function of frequency of the use of the drill. Under the drilling pressure of 750g, it was revealed that the drilling time for an old twist drill that has already drilled 40 times was 4.5 times longer than a new drill The measurement was taken for the first 10 drillings of a new drill and 10 drillings of an old drill that has already been used for 40 drillings. 'Test Statistics' of small samples t-test was 3.49, confirming that the used twist drills require longer drilling time than new ones. On the other hand, it was revealed that there was no significant difference in drilling temperature between the new drill and the old twist drill. Finally, the following conclusions were reached from this study : 1 Used drilling bur causes almost no change in drilling temperature but increase in drilling time through 50 drillings under the manufacturer-recommended cooling conditions and the drilling pressure of 750g. 2. The heat that is generated through drilling mattered only in the case of 2mm twist drills, the first drill to be used in bone drilling process for all the other drills there is no significant problem. 3. If the drilling pressure is increased when a 2mm twist drill reaches a dense bone, the temperature rises abruptly even under the manufacturer-recommended cooling conditions. 4. Drilling heat was the highest at the final moment of the drilling process.

Experimental investigation of the photoneutron production out of the high-energy photon fields at linear accelerator (고에너지 방사선치료 시 치료변수에 따른 광중성자 선량 변화 연구)

  • Kim, Yeon Su;Yoon, In Ha;Bae, Sun Myeong;Kang, Tae Young;Baek, Geum Mun;Kim, Sung Hwan;Nam, Uk Won;Lee, Jae Jin;Park, Yeong Sik
    • The Journal of Korean Society for Radiation Therapy
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    • v.26 no.2
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    • pp.257-264
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    • 2014
  • Purpose : Photoneutron dose in high-energy photon radiotherapy at linear accelerator increase the risk for secondary cancer. The purpose of this investigation is to evaluate the dose variation of photoneutron with different treatment method, flattening filter, dose rate and gantry angle in radiation therapy with high-energy photon beam ($E{\geq}8MeV$). Materials and Methods : TrueBeam $ST{\time}TM$(Ver1.5, Varian, USA) and Korea Tissue Equivalent Proportional Counter (KTEPC) were used to detect the photoneutron dose out of the high-energy photon field. Complex Patient plans using Eclipse planning system (Version 10.0, Varian, USA) was used to experiment with different treatment technique(IMRT, VMAT), condition of flattening filter and three different dose rate. Scattered photoneutron dose was measured at eight different gantry angles with open field (Field size : $5{\time}5cm$). Results : The mean values of the detected photoneutron dose from IMRT and VMAT were $449.7{\mu}Sv$, $2940.7{\mu}Sv$. The mean values of the detected photoneutron dose with Flattening Filter(FF) and Flattening Filter Free(FFF) were measured as $2940.7{\mu}Sv$, $232.0{\mu}Sv$. The mean values of the photoneutron dose for each test plan (case 1, case 2 and case 3) with FFF at the three different dose rate (400, 1200, 2400 MU/min) were $3242.5{\mu}Sv$, $3189.4{\mu}Sv$, $3191.2{\mu}Sv$ with case 1, $3493.2{\mu}Sv$, $3482.6{\mu}Sv$, $3477.2{\mu}Sv$ with case 2 and $4592.2{\mu}Sv$, $4580.0{\mu}Sv$, $4542.3{\mu}Sv$ with case 3, respectively. The mean values of the photoneutron dose at eight different gantry angles ($0^{\circ}$, $45^{\circ}$, $90^{\circ}$, $135^{\circ}$, $180^{\circ}$, $225^{\circ}$, $270^{\circ}$, $315^{\circ}$) were measured as $3.2{\mu}Sv$, $4.3{\mu}Sv$, $5.3{\mu}Sv$, $11.3{\mu}Sv$, $14.7{\mu}Sv$, $11.2{\mu}Sv$, $3.7{\mu}Sv$, $3.0{\mu}Sv$ at 10MV and as $373.7{\mu}Sv$, $369.6{\mu}Sv$, $384.4{\mu}Sv$, $423.6{\mu}Sv$, $447.1{\mu}Sv$, $448.0{\mu}Sv$, $384.5{\mu}Sv$, $377.3{\mu}Sv$ at 15MV. Conclusion : As a result, it is possible to reduce photoneutron dose using FFF mode and VMAT method with TrueBeam $ST{\time}TM$. The risk for secondary cancer of the patients will be decreased with continuous evaluation of the photoneutron dose.