• Title/Summary/Keyword: Clinical Trials

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Biodistribution and Metabolism of I-123 Labelled Fatty Acid(I) : [I-123]15-(p-iodophenyl)pentadecanoic acid(IPPA) (I-123 표지 지방산의 체내 분포 및 대사(I) : [I-123]15-(p-iodophenyl)pentadecanoic acid(IPPA))

  • Chang, Young Soo;Lee, Dong Soo;Jeong, Jae Min;Suh, Yong-Sup;Chung, June-Key;Lee, Myung Chul;Koh, Chang-Soon
    • The Korean Journal of Nuclear Medicine
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    • v.32 no.1
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    • pp.50-60
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    • 1998
  • I-123 labelled fatty acids are suitable for investigation of regional myocardial metabolism, so they are on the clinical trial. However, the precise properties of these materials are not characterized yet. We have synthesized phenylpentadecanoic acid and labeled this compound with I-123. The purpose of this study was to examine the stability, biodistribution, metabolism and SPECT imaging of [I-123]15-(p-iodophenyl)pentadecanoic acid(I-123-IPPA) that we made. The stability test of I-123-IPPA in serum of rat, mouse and human showed no free I-123 after 1 hour. In biodistribution study in mice for various time intervals after injection(5, 10, 15, 30, 60 minutes), uptake in myocardium was 14.5%ID/g(5 min), and 1.9%ID/heart(5 min), while uptake in muscles was 2.6%ID/g(5 min). Myocardium to blood ratio and myocardium to lung ratio increased for 5 min after injection and then decreased rapidly. Chromatographic data of rat blood and urine showed that little PPA was found in blood and urine at 15-20 min after injection. The myocardial I-123-IPPA SPECT images of a dog with myocardial infarction showed defects similar to those of Tc-99m-MIBI and F-18-FDG. These data suggest that I-123-IPPA is quite stable in vitro and shows favorable biodistribution in mice. SPECT imaging with I-123-IPPA demonstrated infarct zone as photon defect in dog model of myocardial infarction. I-123-IPPA may be used for the evaluation of fatty acid metabolism in clinical trials in Korea.

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Sequential Chemotherapy and Radiation Therapy for Advanced Nasopharyngeal Carcinoma (진행된 비인강암의 화학요법 및 방사선 치료)

  • Park, In-Kyu;Kim, Song-Bo;Yun, Sang-Mo;Kim, Jae-Cheol;Park, Jun-Sik
    • Radiation Oncology Journal
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    • v.11 no.2
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    • pp.259-265
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    • 1993
  • Between January 1985 and July 1992, 52 patients with locally advanced nasopharyngeal carcinoma were studied retrospectively for the effectiveness of sequential chemotherapy and radiation therapy. The male to female ratio was 3.3:1 with a median age of 41 years. Forty patients had squamous cell carcinoma and the remaining 12 had undifferentiated carcinoma. Seven patients had stage III disease and the remainder had stage IV disease at time of presentation. All patients were treated two courses of chemotherapy followed by radiation therapy. Chemotherapy consisted of either CVB (cisplatin, vincristine and bleomycin) or CF (cisplatin and 5-FU). Total radiation dose to the primary site ranged from 6000 cGy to 7500 cGy. Neck nodes were given booster treatment to maximum of 7000 cGy, depending on the extent of disease. Local control, overall survival and disease-free survival rates were analyzed. The complete response (CR) rate to chemotherapy was $15\%$ and the partial response (PR) rate was $46\%,$ for overall major response rate of $61\%.$ The CR rate was $87\%$ after radiation therapy. Median follow-up time was 51 months. The overall survival and disease-free survival rates at 36 months were $54\%\;and\;49\%,$ respectively. Median time to relapse was 15 months. The patterns of initial relapse in CR patients was as follows: locoregional failure only, 12 patients; distant metastasis only,11: both,2. Cox's multivariate regression model revealed that nodal status was the single most important independant prognostic factor influencing disease-free survival (p=0.001). Comparision of these results with other published reports with radiation therapy alone showed that a high rate of initial response to chemotherapy did not translate into local control or survival. At present time radiation therapy alone remains the standard treatment for locoregional cancer of the nasopharyngeal cancer. More controlled clinical trials must be completed before acceptance of chemotherapy as a part of treatment of advanced nasopharyngeal carcinoma.

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Fractionated Stereotactic Radiation Therapy for Intracranial Benign Tumor : Preliminary Results of Clinical Application (양성 뇌종양의 분할정위 방사선치료 : 임상적 응용의 예비적 결과)

  • Kim Dae Yong;Ahn Yong Chan;Huh Seung Jae;Choi Dong Rak;Nam Jong Hyun;Lee Jung Il;Park Kwan;Nam Do-Hyun;Kim Moon Kyung
    • Radiation Oncology Journal
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    • v.16 no.2
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    • pp.185-194
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    • 1998
  • Purpose : With the development of stereotactic immobilization systems capable of reliable serial repositioning, fractionated stereotactic radiation therapy (FSRT) offers the Potential for an improved treatment outcome by excellent dose delivery, and dose distribution characteristics with the favorable radiobiological properties of fractionated irradiation. We describe our initial experience using FSRT for the treatment of intracranial benign tumor. Materials and Methods : Between August 1995 and December 1996. 15 patients(7 males and 8 females aged 6-70 years) were treated with FSRT. The patients had the following diagnosis pituitary adenoma(10) including one patient who previously had received radiotherapy, craniopharyngioma (2), acoustic neurinoma (1), meningioma (2). Using the Gill-Thomas-Cosman relocatable head frame and multiple non-coplanar therapy, the daily dose of 2Gy was irradiated at 90% to 100% isodose surface of the isocenter The collimator sizes ranged from 26mm to 70mm. Results : In all patients except one follow-up lost, disease was well-controlled. Acute complication was negligible and no patient experienced cranial nerve neuropathies and radiation necrosis. In overall patient setup with scalp measurements, reproducibility was found to have mean of $1.1{\pm}0.6mm$ from the baseline reading. Conclusion : Relocatable stereotactic system for FSRT is highly reproducible and comfortable. Although the follow-up period was relatively short. FSRT is considered to be a safe and effective radiation technique as the treatment of intracranial tumor. But the fractionation schedule(fraction size, overall treatment time and total dose) still remains to be solved by further clinical trials.

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A Study on the Moisturizing Effect and Preparation of Liquid Crystal Structures Using Sucrose Distearate Emulsifier (슈크로오스디스테아레이트를 사용한 액정구조의 생성과 보습효과에 관한 연구)

  • Kwak, Myeong-Heon;Kim, In-Young;Lee, Hwan-Myung;Park, Joo-Hoon
    • Journal of the Korean Applied Science and Technology
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    • v.33 no.1
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    • pp.1-12
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    • 2016
  • This study is to make the liquid crystalline structure using sucrose distearate (Sucro-DS) emulsifier to create the hydrophilic type oil-in-water (O/W) emulsion, the droplets of the emulsion having a structure of a multi-lamellar structure. We have studied the physicochemical properties of Sucro-DS using those techniques. And it has been studied in the emulsion performance. In order to form the liquid crystalline structure applying 3 wt% of Sucro-DS, 5 wt% of glycerin, 5 wt% of squalane, 5 wt% of capric/caprylic triglyceride, 3wt% of cetostearyl alcohol, 1wt% of glyceryl mono-stearate, 78 wt% of pure water in mixture having the lamellar structure of stable multi-layer system was found to formed. By applying them, they were described how to create an unstable active material encapsulated cream. Further, the moisturizing cream was studied using this technique. It reported the results to the skin improvement effect by the human clinical trials. The pH range to produce a stable liquid crystal phase using a Sucro-DS was maintained in 5.2~7.5. In order to increase the stability of the liquid crystal, it was when behenyl alcohol containing 3 wt%, the hardness at this time was 13 kg/mm,min. Viscosity of the same amount was 25,000mPas/min. After a test for the effects of the emulsions, the concentration of 6 wt% Sucro-DS is that was appropriate, the particle size of the liquid crystal was 4~6mm. It was observed through a microscope analysis, reliability of the liquid crystal changes for 3 months was found to get stable at each $4^{\circ}C$, $25^{\circ}C$ and $45^{\circ}C$. In clinical trial test, before applying a moisturizing effect it was $13.4{\pm}7%$. Moisturizing cream liquid crystal was not formed in $14.5{\pm}5%$. Therefore, applying than ever before could see the moisture about 8.2% was improved. On the other hand, it was the moisturizing effect of the liquid cream is $19.2{\pm}7%$. The results showed that 43.3% improvement than that previously used. Applications fields, Sucro-DS emulsifier used liquid cream, lotion, eye cream and a variety of formulations can be developed, as well as the cosmetics industry is expected to be wide fields in the application of the external preparation for skin emulsion technology in the pharmaceutical industry and pharmaceutical industry.

The influence of magnet on tissue healing after immediate implantation in fresh extraction sites in dogs (성견에서 발치 후 즉시 식립 임플란트에 설치한 자석이 주위 조직에 미치는 영향)

  • Yu, Seok-Min;Cho, In-Ho;Shin, Soo-Yeon
    • The Journal of Korean Academy of Prosthodontics
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    • v.47 no.4
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    • pp.435-444
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    • 2009
  • Statement of problem: The clinical use of electric and electomagnetic fields for fracture healing applications began in the early 1970s. Since then, several technologies have been developed and shown to promote healing of fractures. Developments of these devices have been aided in recent years by basic research and several well controlled clinical trials not only in the medical field but in dentistry. Purpose: The purpose of this study was to compare alveolar bone reduction following immediate implantation using implants onto which magnets were attached in fresh extracted sockets. Material and methods: Four mongrel dogs were involved. Full buccal and lingual mucoperiosteal flaps were elevated and third and fourth premolars of the mandible were removed. Implants with magnets and implants without magnets were installed in the fresh extracted sockets and after 3 months of healing the animals were sacrificed. The mandibles were dissected and each implant sites were sampled and processed for histological examination. Results: The marginal gaps that were present between the implant and walls of the sockets at the implantation stage disappeared in both groups as a result of bone fill and resorption of the bone crest. The buccal bone crests were located apical of its lingual counterparts. At the 12 week interval the mean of marginal bone resorption in the control group was significantly higher than that of the magnet group. The majority of specimens in magnet group presented early bone formation and less resorption of the buccal marginal bone compared to the control group. Conclusion: Within the limitations of this study, it could be concluded that implants with magnets attached in the early stages of implantation may provide more favorable conditions for early bone formation and reduce resorption and remodeling of marginal bone.

Study for the Synthesis of $[^{123}I]$Idoxifene and Its Uptake in the Breast Cancer Cell ($[^{123}I]$Idoxifene 합성과 유방암의 세포섭취에 관한 연구)

  • Cho, Young-Sub;Yang, Seung-Dae;Suh, Yong-Sup;Chun, Kwon-Soo;Ahn, Soon-Hyuk;Lim, Soo-Jung;Lim, Sang-Moo;Yu, Kook-Hyun
    • The Korean Journal of Nuclear Medicine
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    • v.34 no.5
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    • pp.410-417
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    • 2000
  • Purpose: Idoxifene is currently entering phase II clinical trials for the treatment of advanced breast cancer. The radiolabeled idoxifene using $[^{123}I]$ provides an opportunity for clinical pharmacology with single photon emission computed tomography (SPECT). The purpose of this study was to prepare radiolabeled idoxifene using $[^{123}I]$ and to determine its cell uptake of breast cancer cell line. Materials and Methods: With a view to evaluating new anticancer drugs, we are investigating the novel antiestrogen pyrrolidino-4-iodotamoxifen (idoxifene). $[^{123}I]$Idoxifene has been prepared in no-carrier-added form using a tributyl stannylated precursor which has been synthesized by means of (2-chloroethoxy)benzene with (${\pm}$)-2-phenylbutanoic acid on the basis of previously reported standard methods. The biodistribution and dynamic behavior of the compound were investigated using the comparative breast cancer cell line, MCF-7 (estrogen receptor-positive) and MDA-MB-468 (non-estrogen receptor). Results and Conclusion: Acylation of (2-chloroethoxy)benzene with (${\pm}$)-2-phenylbutanoic acid gave the versatile ketone (81%) which reacted with 1,4-diiodobenzene to give triphenylethylene as a mixture of E and Z geometric isomers, which were separated by the recrystallization in ethanol. The E-isomer was treated with pyrrolidine to give idoxifene (67%). In order to incorporate radioactive iodine into the 4-position, the 4-stannylated precursor was prepared (30%). The yield of radioiodination was 90-92% with a high radiochemical purity greater than 98%. The ratio of tumor uptake of the breast cancer cell line between MCF-7 and MDA-MB-468 was about 1.7.

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Radiotherapy Results of Uterine Cervix Cancer Stape IIB : Overall Survival, Prognostic factors, Patterns of Failure and Late Complications (자궁경부암 병기 IIB에서의 방사선 치료 성적: 생존율 및 예후인자, 치료 후 실패양상, 만성 합병증)

  • Kim Eun-Seog;Choi Doo-Ho;Huh Seung-Jae
    • Radiation Oncology Journal
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    • v.16 no.1
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    • pp.51-61
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    • 1998
  • Purpose : Treatment of choice for uterine cervix cancer stage IIB is radiotherapy. We analyzed survivals, Prognostic factors, patterns of failure and complications. Materials and Methods : This is a retrospective analysis of 167 patients with stage IIB carcinoma of uterine cervix treated with curative external pelvic and high dose rate intracavitary radiotherapy at the Department of Therapeutic Radiology, Soonchunhyang University Hospital from August 1985 to August 1994. All the patients followed up from 3 to 141 months(mean 60 months) and age of patients ranged from 31 to 78 years at presentation(mean : 55 years). Results : Overall complete response rate was $84\%$. The response rate for squamous cell carcimoma and adenocarcinoma were $86\%$ and $60\%$, respectively. Overall 5-years survival rate and disease free survival rate was 62 and $59\%$, respectively Mass size and treatment response were significant Prognostic factors for survival Pathologic type and parametrial involvement were marginally significants Prognostic factors. Local failure was 43 cases, distant metastasis was 14 cases and local failure plus distant metastasis was 3 cases, and most of local failures occurred within 24 months, distant metastasis within 12 months after treatment Twenty eight($16.8\%$) patients developed late rectal and urinary complications There were tendency to increasing severity and frequency according to increased fractional dose and total(rectal and bladder) dose. Conclusions : Survival rate was significantly related to tumor size and radiotherapy response. Tumor size should be considered in the clinical s1aging. To increased survival and local control, clinical trials such as decreasing duration of radiotherapy or addition of chemotherapy is needed. To detect early recurrence, regular follow up after RT is important. Because total rectal and bladder dose affected late complications. meticulous vaginal packing is needed to optimize dose of normal tissues and to decrease late complications.

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A Study on the Quality Control of Transvaginal Ultrasound Transducer using ATS-539 Ultrasound Phantom (ATS-539 초음파 팬텀을 이용한 경질 초음파 검사용 탐촉자의 정도관리에 대한 연구)

  • Park, Ji Hye;Heo, Yeong Cheol;Kim, Yon min;Han, Dong Kyoon
    • Journal of the Korean Society of Radiology
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    • v.15 no.4
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    • pp.463-472
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    • 2021
  • Demand for examinations using transvaginal transducer with high frequencies is increasing to observe pelvic organs in gynecological ultrasound tests. However, the quality control of the replacement probe in clinical trials is not properly implemented and the evaluation criteria have not been established. Therefore, 58 transvaginal transducers and 20 convex transducers were applied to the ATS-539 ultrasound phantom for 20 ultrasound devices currently in clinical use to obtain their respective images and measure them quantitatively and qualitatively. For quantitative measurements, vertical measurement, horizontal measurement, and focal zone and qualitative measurements, dead zone, axial·lateral resolution, sensitivity, functional resolution, gray scale·dynamic range were performed. Quantitative statistical analysis showed significant differences between the two transducers in the lateral measurement and local area (p<0.05). qualitative comparative analysis showed differences in sensitivity and functional resolution. This occurs due to the difference in frequency between transducers and the transducer's injection geometry. Based on the above experiments, the tolerance for horizontal measurement is raised to 10% (±8 mm), the tolerance for sensitivity is observed up to 6 cm deep, which is 12 cm deep,which is the level of the third quartile (75%). The permissible range of functional resolution is up to 6 (12 cm), 6 (12 cm), 11 (11 cm), 9 (9 cm), 6 (6 cm) target, which is the level of the third quartile (75%). It is considered reasonable to adjust the depth of targets in gray scale·dynamic range to measure at a depth of 2 cm, which is 50% of the depth of 4 cm. As above, the criteria for evaluating the quality of transvaginal transducer for use in the past have been proposed and it is expected that this study will be used as a basic data for the production of phantom exclusively for transvaginal transducer in the future.

Neurotechnologies and civil law issues (뇌신경과학 연구 및 기술에 대한 민사법적 대응)

  • SooJeong Kim
    • The Korean Society of Law and Medicine
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    • v.24 no.2
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    • pp.147-196
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    • 2023
  • Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

Low Dose Cisplatin as a Radiation Sensitizer in Management of Locally Advanced Scluamous Cell Carcinoma of the Uterine Cervix : Evaluation of Acute Toxicity and Early Response (국소 진행된 자궁경부암의 방사선치료와 저용량 cisplatin 항암요법 동시치료시 급성독성 밀 초기반응 평가)

  • Kim Hunjung;Cho Young Kap;Kim Chulsu;Kim Woo Chul;Lee Sukho;Loh J K
    • Radiation Oncology Journal
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    • v.17 no.2
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    • pp.113-119
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    • 1999
  • Purpose : To evaluate possible acute toxicity and early response of concurrent radiation therapy and low dose daily cisplatin as a radiosensitizer in patients with locally advanced uterine cervical carcinomas. Materials and Method : From December 1996 to January 1999, 38 previously untreated Patients with locally advanced squamous cell carcinoma of the uterine cervix (from stage IIB to stage IIIB) were treated at Inha University Hospital. All patients underwent standard pretreatment staging Procedures after the initial evaluation by gynecologists and radiation oncologists. Sixteen Patients with huge cervical mass (>4 cm) were submitted to the group treated with concurrent radiation therapy and low dose daily cisplatin while the remainder was treated with radiation therapy alone. Radiation therapy consisted of 4500 cGy external beam irradiation to whole pelvis (midline block after 3000 cGy), 900$\~$1000 cGy boost to involved parametrium, and high dose-rate intracavitary brachytherapy (a total dose of 3000$\~$3500 cGy/500 cGy per fraction to point A, twice per week). In the group treated with low dose cisplatin concurrently, 10 mg of daily intravenous cisplatin was given from the 1st day of radiation therapy to the 20th day of radiation therapy. Acute toxicity was measured according to expanded common toxicity criteria of the NCI (C) Clinical Trials. Early response data were analyzed at minimum 4 weeks' follow-up after completion of the treatment protocol. Results: Hematolgic toxici쇼 was more prominent in patients treated with radiation therapy and cisplatin. Six of 16 patients (37.5$\~$) treated with radiation therapy and cisplatin and one of 22 patients (4.5$\~$) treated with radiation therapy alone experienced grade 3 leukopenia. In Fisher's exact test, there was statistically significant difference between two groups regarding leukopenia (P=0.030). There was no apparent difference in the frequency of gastrointestinal and genitourinary toxicity between two groups (P=0.066). Three of 16 patients (18.7$\~$) treated with radiation therapy and cisplatin and two of 22 patients (9.1$\~$) treated with radiation therapy alone experienced more than 5 kg weight loss during the treatment. There was no statistically significant difference on weight loss between two groups (P=0.63). Two patients on each group were not evaluable for the early response because of incomplete treatment. The complete response rate at four weeks' follow-up was 80$\~$(16/20) for the radiation therapy alone group and 78$\~$ (11/14) for the radiation therapy and cisplatin group. There was no statistically significant difference in early response between two treatment groups (P=0.126). Conclusion : This study led to the conclusion that the hematologic toxicity from the treatment with concurrent radiation therapy and low dose daily cisplatin seems to be more prominent than that from the treatment of radiation therapy alone. There was no grade 4 hematologic toxicity or mortality in both groups. The hematologic toxicity in both treatment groups seems to be well managable modically. Since the risk factors were not balanced between two treatment groups, the direct comparison of early response of both groups was not possible. However, preliminary results regarding early response for patients with bulky cervical tumor mass treated with radiation therapy and low dose daily cisplatin was encouraging. Longer follow-up is necessary to evaluate the survival data. A phase III study is needed to evaluate the efficacy of concurrent daily low dose cisplatin with radiation therapy in bulky cervical cancer.

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