• Title/Summary/Keyword: diagnostic antigen

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Evaluation of a Rapid Diagnostic Antigen Test Kit Ribotest Mycoplasma® for the Detection of Mycoplasma pneumoniae (Mycoplasma pneumoniae 감염의 신속 항원 검사 키트 "Ribotest Mycoplasma®"의 진단적 평가)

  • Yang, Song I;Han, Mi Seon;Kim, Sun Jung;Lee, Seong Yeon;Choi, Eun Hwa
    • Pediatric Infection and Vaccine
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    • v.26 no.2
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    • pp.81-88
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    • 2019
  • Purpose: Early detection of Mycoplasma pneumoniae is important for appropriate antimicrobial therapy in children with pneumonia. This study aimed to evaluate the diagnostic value of a rapid antigen test kit in detecting M. pneumoniae from respiratory specimens in children with lower respiratory tract infection (LRTI). Methods: A total of 215 nasopharyngeal aspirates (NPAs) were selected from a pool of NPAs that had been obtained from children admitted for LRTI from August 2010 to August 2018. The specimens had been tested for M. pneumoniae by culture and stored at $-70^{\circ}C$ until use. Tests with Ribotest $Mycoplasma^{(R)}$ were performed and interpreted independently by two investigators who were blinded to the culture results. Results: Among the 215 NPAs, 119 were culture positive for M. pneumoniae and 96 were culture negative. Of the culture-positive specimens, 74 (62.2%) were positive for M. pneumoniae by Ribotest $Mycoplasma^{(R)}$, and 92 of the 96 (95.8%) culture-negative specimens were negative for M. pneumoniae by Ribotest $Mycoplasma^{(R)}$. When culture was used as the standard test, the sensitivity and specificity of Ribotest $Mycoplasma^{(R)}$ were 62.2% and 95.8%, respectively. Additionally, the positive predictive value, negative predictive value, and overall agreement rates with Ribotest $Mycoplasma^{(R)}$ were 94.9%, 67.2%, and 77.2%, respectively. Conclusions: A positive test result of Ribotest $Mycoplasma^{(R)}$ suggests a high likelihood of culture-positive M. pneumoniae infection. However, a negative test result should be interpreted with caution because nearly one-third of negative test results reveal culture-positive M. pneumoniae infections.

Diagnostic Usefulness of Serum Level of Cyfra 21-1, SCC Antigen and CEA in Lung Cancer (폐암에서 혈중 Cyfra 21-1, SCC 항원 및 CEA의 진단적 유용성)

  • Kim, Kyoung-Ah;Lee, Me-Hwa;Koh, Youn-Suck;Kim, Seon-Hee;Lim, Chae-Man;Lee, Sang-Do;Kim, Woo-Sung;Kim, Dong-Soon;Kim, Won-Dong;Moon, Dae-Hyuk
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.6
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    • pp.846-854
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    • 1995
  • Background: Cytokeratin 19 is a subunit of cytokeratin intermediate filament expressed in simple epithelia such as respiratory epithelial cells and their malignant counterparts. An immunoradiometric assay is available to detect a fragment of the cytokeratin, referred to as Cyfra 21-1 in the serum. This study was conducted to evaluate the clinical utility of this new marker in the diagnosis of lung cancer compared with established markers of squamous cell carcinoma antigen (SCC Ag) and carcino-embryonic antigen(CEA). In addition, we compared the diagnostic sensitivity and specificity of Cyfra 21-1 with those of SCC Ag in squamous cell carcinoma of the lung. We also measured the level of Cyfra 21-1 in the different stages of squamous cell carcinoma of the lung. Method: We measured Cyfra 21-1(ELSA-CYFRA 21-1), SCC Ag(ABBOTT SCC RIABEAD) and CEA(ELSA2-CEA) in 79 patients with primary lung cancer and in 78 persons as a comparison group including 32 patients with pulmonary tuberculosis, 23 patients with benign lung disease and 23 cases with healthy individual. Cyfra 21-1 is measured by a solid-phase immunoradiometric assay(CIS Bio International, France) based on the two-site sandwich method. SCC Ag is measured by a radioimmunoassay(Abbott Laboratories, USA). CEA is measured by a immunoradiometric assay(CIS Bio International, France). All data were expressed as the mean$\pm$standard deviation. Results: 1) The mean value of Cyfra 21-1 was $18.38{\pm}3.65\;ng/mL$ in the lung cancer and $1.l6{\pm}0.53\;ng/mL$ in the comparison group(p<0.0001). SCC Ag was $3.53{\pm}6.06\;ng/mL$ in the lung cancer and $1.19{\pm}0.5\;ng/mL$ in the comparison group(p<0.01). CEA was $35.03{\pm}13.9\;ng/mL$ in the lung cancer and $2.89{\pm}1.01\;ng/mL$ in the comparison group(p<0.0001). 2) Cyfra 21-1 level in squamous cell carcinoma($31.52{\pm}40.13\;ng/mL$) was higher than that in adenocarcinoma($2.41{\pm}1.34\;ng/mL$)(p<0.0001) and small cell carcinoma($2.15{\pm}2.05\;ng/mL$)(p=0.007). SCC Ag level in squamous cell carcinoma($5.1{\pm}7.68\;ng/mL$) was higher than that in adenocarcinoma($1.36{\pm}0.69\;ng/mL$)(p=0.009) and small cell carcinoma($1.1{\pm}0.24\;ng/mL$) (p=0.024). 3) The level of Cyfra 21-1 was not correlated with the progression of stage in squamous cell carcinoma of the lung. 4) Using the cut-off value of 3.3ng/mL, the diagnostic sensitivity of Cyfra 21-1 was 83% in squamous cell carcinoma, 22% in adenocarcinoma and 17% in small cell carcinoma. The sensitivity of SCC Ag and CEA were 39% and 20%, respectively in squamous cell carcinoma, 11% and 39% in adenocarcinoma, and 0% and 33% in small cell carcinoma. 5) Comparison of the receiver operating characteristics curves(ROC curve) for Cyfra 21-1, SCC Ag and CEA revealed that Cyfra 21-1 showed highest diagnostic sensitivity among them in the diagnosis of lung cancer. Conclusion: Cyfra 21-1 is thought to be a better tumor marker for the diagnosis of lung cancer than SCC Ag and CEA, especially in squamous cell carcinoma of the lung.

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Evaluation of an ELISA kit for the Serodiagnosis of Pulmonary Tuberculosis by Using Mixed Antigens of Mycobacterium Tuberculosis (폐결핵진단에서 결핵균 혼합항원을 이용한 혈청학적 검사의 유용성에 관한연구)

  • Park, Seung-Kyu;Kim, Phil-Ho;Kim, Seung-Chul;Choi, In-Hwan;Cho, Sang-Nae;Song, Sun-Dae
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.5
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    • pp.558-567
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    • 2000
  • Background : Recently, serologic techniques for tuberculosis have been developed and some of them, which are focusing on detection of serum antibodies mainly directed against specific 38-kDa Mycobacterium tuberculosis, have already been introduced into the markel. In this study, diagnostic significance of a new serologic test(ELISA kit) for pulmonary tuberculosis was evaluated. Method : Serologic test with newly developed ELISA kit was performed upon 474 individuals, who include 333 active pulmonary tuberculosis patients, 80 healthy cases, and 61 tuberculosis contact cases. This serologic test was based on the ELISA technique and designed to detect antibodies to mixed complex antigens including 38-kDa, which were developed by Erume Biotech Co., Seoul. Active pulmonary tuberculosis was diagnosed by sputum AFB smear and culture methods. Results : The seropositivities using this ELISA kit were 82.1% and 73.6% in smear-positive and negative groups among active pulmonary tuberculosis, respectively. And, it also showed that seronegativities were 97.5% and 85.2% in healthy and contact groups, respectively. As a whole, the results of our study using the ELISA kit as a diagnostic method for pulmonary tuberculosis showed 80.0% sensitivity for active pulmonary tuberculosis, 97.5% specificity, 96.1% positive predictive value, and 65.0% negative predictive value when the prevalence of tuberuclosis in the samples was 60.1%. Conclusion : Our results reveal that the detection of antibody its reaction with 38-kDa antigen of M. tuberculosis is not sufficient to be accepted as single diagnostic method for pulmonary tuberculosis. However, they suggest that ELISA kit may be considered as an adjunctive test to standard diagnostic techniques of pulmonary tuberculosis.

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The Utility of MAGE Gene Detection in Bronchial Washing Fluid for Patients with Peripheral NSCLC (말초 비소세포폐암 환자에서 기관지 세척액 MAGE 유전자 진단의 유용성)

  • Kim, Suhyun;Kim, Hojoong;Kwon, O Jung;Chung, Man Pyo;Suh, Gee Young;Koh, Won-Jung;Ham, Cho Rom;Nam, Hae Seong;Um, Sang-Won;Kwon, Yong Soo;Park, Sung-Hoon
    • Tuberculosis and Respiratory Diseases
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    • v.64 no.1
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    • pp.15-21
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    • 2008
  • Background: The melanoma antigen-encoding (MAGE) genes are known to be expressed in various cancer cells, including non-small cell lung cancer (NSCLC), and are silent in all normal tissues except for the testis. In patients with peripheral NSCLC, bronchial washing fluid can be used to detect the MAGE genes, suggesting a diagnosis of lung cancer. In order to evaluate the diagnostic utility of the MAGE test in patients with peripheral NSCLC, bronchial washing fluid was investigated in patients with peripheral pulmonary nodules, which were invisible as detected by bronchoscopy. Methods: Bronchial washing fluid from 37 patients was used for cytological examinations and MAGE gene detection, using RT-nested-PCR of common A1-A6 mRNA. Results were compared to a final diagnosis of patients as confirmed by pathology. Results: Among the 37 subjects, NSCLC was diagnosed in 21 patients, and benign pulmonary diseases were diagnosed in 16 patients. MAGE mRNA was detected in 10 of 21 (47.6%) NSCLC patients, while conventional cytology examinations were positive for MAGE expression in 2 of 21 (9.5%) cases. MAGE expression was observed in 4 of 16 (25%) benign pulmonary disease patients. Conclusion: The MAGE test of bronchial washing fluid can be used as a sensitive predictor of peripheral NSCLC patients.

Clinical Significance of the Combined Assay of Pleural Fluid ADA Activity and CEA Level in the Various Pleural Effusions (흉막삼출 원인질환의 감별진단에 있어서 흉막액 Adenosine Deaminase 활성도 및 Carcinoembryonic Antigen 병행측정의 임상적 의의)

  • Lee, Jang-Hoon;Jang, Sang-Ho;Lee, Hong-Lyeol;Kwak, Seung-Min;Chang, Jung-Hyun;Kim, Byung-Il;Cheon, Sun-Hee;Kim, Se-Kyu;Chang, Joong;Kim, Sung-Kyu;Lee, Won-Young
    • Tuberculosis and Respiratory Diseases
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    • v.40 no.1
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    • pp.35-42
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    • 1993
  • Background: In order to establish the etiology of the pleural effusion, routine analysis of the fluid, bacteriologic studies, cytologic tests and pleural biopsies are currently being employed. However, even with the above mentioned tests, the exact causes cannot be determined in approximately 10-20% of cases. The purpose of our study is to determine the diagnostic value of measuring ADA activity and CEA simultaneously in various pleural fluids which their etiologies have confirmed Methods: We have studied 61 cases of tuberculous pleural effusions, 17 cases of suspected tuberculous pleural effusions, 17 cases of malignant pleural effusions, 22 cases of suspected malignant pleural effusions, and 7 cases of parapneumonic pleural effusions. We have measured the ADA activity and CEA level simultaneously in pleural fluid samples in each cases. Results: 1) The ADA activity in tuberculous pleural effusion was significantly higher than that in malignant effusion. 2) The CEA level in malignant pleural effusion was significantly higher than that in tuberculous effusion. 3) With the cut-off values of the pleural fluid ADA activity more than 40 U/L and the CEA level less than 12 ng/mL, the sensitivity was 86.9%, and the specificity was 100% in the diagnosis of tuberculous effusion. With the cut-off values of the pleural fluid CEA level more than 12 g/mL and the ADA activity less than 40 U/L, the sensitivity was 76.5%, and the specificity was 100% in the diagnosis of malignant effusion. Conclusion: It is suggested that the combined assay of pleural fluid ADA activity and CEA level is very useful in the differential diagnosis of tuberculous and malignant pleural effusion.

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Expression of Several Biologic Markers as Prognostic Markers in Non-Small Cell Lung Cancers (폐암조직에서 생물학적 지표들의 예후인자로서의 비교검토)

  • Kim, Sun-Young;Cho, Hai-Jeong;Suh, Ji-Won;Kim, Nam-Jae;Kim, Ju-Ock
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.2
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    • pp.142-148
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    • 1995
  • Background: Despite modern diagnostic, staging, and therapeutic advances, esp. with molecular biologic techniques, the 5-year survival rate of all cases of lung cancer does not exceed 15%. Also, the incidence of lung cancer of both sex in Korea is increasing year by year and the lung cancer is one of the leading causes of cancer death. Therefore, it is strongly needed to develop the new combination of treatment modalities including neoadjuvant chemotherapy and to identify tumor specific characteristics with staging or prognostic markers. Here we present the clinical significance of several biologic tumor markers to use as a prognostic markers in patients with non-small cell lung cancers. Method: The survival has correlated with the expressibility of proliferative cell nuclear antigen (PCNA), epidermal growth factor receptor(EGFR), p53 and/or blood group antigen A(BGAA) using immunohistochemistry in 46 patients with non-small cell lung cancers. Results: 1) The expression rates of PCNA, EGFR, p53 and BGAA were 80.6%, 61.3%, 45.9% and 64.3%, respectively and those were not correlated to cell types or clinical stges. 2) The expression of BGAA was correlated with better survival in median survival and in 2-year survival rate and that of PCNA was correlated with worse survival in median survival and 2-year survival rate. 3) The expression of EGFR or p53 was not valuable to predict prognosis in non-small cell lung cancers. 4) With simultaneous applications of PCNA, EGFR and p53 immunostain, the patients with 2 or more negative expressions showed better prognosis than the patients with 2 or more positive expressions. Conclusion: It is suggested that the expression of blood group antigen may be a positive prognostic factor and that of PCNA may be a negative prognostic factor. Also, the combination of expressions of PCNA, EGFR and p53 may be used as a negative prognostic factor.

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Diagnostic Utility of MAGE Expression in Exudative Pleural Effusion (삼출성 흉수에서 악성 감별을 위한 MAGE 유전자 검출의 의의)

  • Kim, Kyung Chan;Seo, Chang Gyun;Park, Sun Hyo;Choi, Won-Il;Han, Seung Beom;Jeon, Young June;Park, Jong-Wook;Jeon, Chang-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.56 no.2
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    • pp.159-168
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    • 2004
  • Background : In recent years, numerous human tumor specific antigens such as melanoma antigen gene(MAGE) that is recognized by autologous cytotoxic T lymphocytes have been identified. MAGE is expressed in many human malignancies in various organs, such as lung, breast, stomach, esophagus and leukemia. Therefore MAGE has been studied widely for tumor diagnosis and immunotherapy. But, so far there were no clinical studies evaluating the role of MAGE in pleural effusion. We investigated the expression of MAGE in the patients with exudative pleural effusion for it's diagnostic utility and the results were compared with those of cytologic examinations. Methods : Diagnostic thoracentesis was performed in 44 consecutive patients with exudative pleural effusion during 6 months. We examined the expression of MAGE and cytology with the obtained pleural effusion. Expression of MAGE was interpreted by means of a commercial kit using RT-PCR method. Enrolled patients were divided into two groups such as malignant and benign and we analyzed its' sensitivity and specificity. Results : There were no significant differences between two groups in age, sex, white blood cell counts in pleural fluid, pleural fluid/serum protein ratio and pleural fluid/serum LDH ratio. The sensitivity and specificity of MAGE were 72.2% and 96.2% respectively and the positive predictive value and negative predictive value of MAGE were also 92.9% and 83.3% respectively. The sensitivity and negative predictive value of cytologic examinations were 66.7% and 81.3% respectively. There were no significant differences between sensitivities of MAGE and cytologic examinations but false positive result of MAGE was found in 1 case of tuberculous pleurisy. Conclusion : MAGE is a sensitive and specific marker for the differential diagnosis between benign and malignant effusion in patients with exudative pleural effusion. And MAGE would provide the equal sensitivity compared with that of cytologic examination in patients with malignant pleural effusion if 5mL of the pleural fluid is examined.

Evaluating the Usefulness of the ICT Tuberculosis Test Kit for the Diagnosis of Tuberculosis (결핵 진단에서 ICT Tuberculosis Test Kit의 효용성)

  • Chang, Chul-Hun;Son, Han-Chul;Ryu, Ki-Chan;Park, Soon-Kew;Lee, Seon-Ho;Kim, Sung-Ryul;Park, Ki-Hyung;Kim, Woo-Seok;Koo, Kyong-Soo
    • Tuberculosis and Respiratory Diseases
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    • v.46 no.4
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    • pp.473-480
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    • 1999
  • Background: Early diagnosis of tuberculosis is critical, especially in Korea, an area where tuberculosis is endemic. Because antibody responses to some membrane proteins of Mycobacterium tuberculosis are not comparable, and the policy of BCG vaccination and the prevalence of tuberculosis are different from country to country, the usefulness of the serological diagnostic tests is questionable in Korea, even though they have been confirmed to be useful in other countries. In the specific context of Korea, we tried to evaluate the validity of the ICT Tuberculosis Test (ICT), a membrane-based antibody kit that purports to detect the 5 M. tuberculosis complex-specific antigens including 38-kDa protein. Method: 68 patients with tuberculosis were tested : 37 had no history of previous tuberculosis, and 31 were reactivated cases. The control group comprised 77 subjects : 25 healthy adults, 35 hospital workers with frequent contact with tuberculosis patients, and 17 in-patients with non-tuberculous respiratory diseases. Results: The diagnostic sensitivities of the ICT were 87% and 73% in patients with versus without previous history of tuberculosis, respectively. The sensitivities of smear-positive and smear-negative patient groups were 81% and 73%, respectively. Both of the two patients with extrapulmonary tuberculosis tested positive through the ICT. The specificities of the ICT were 88%, 94%, and 94% in healthy adults, hospital workers, and non-tuberculous patients, respectively, with an overall specificity of 92%. Conclusion: It is suggested that when combined with traditional techniques, the ICT is an useful tool for the diagnosis of pulmonary tuberculosis. The procedure is simple, easy to perform, rapid, and needs no equipment. It shows 73% sensitivity and 92% specificity for the diagnosis of tuberculosis.

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Usefulness of Escherichia coli-expressed Recombinant VP6 Proteins of Group A Rotavirus in Serodiagosis of Rotavirus Infection (대장균에서 발현된 A군 로타바이러스 VP6 단백질을 이용한 로타바이러스 감염의 혈청학적 진단의 유용성)

  • Seo, Ji-Hyun;Kim, So-Young;Park, Ji-Sook;Lim, Jae-Young;Park, Chan-Hoo;Woo, Hyang-Ok;Youn, Hee-Shang;Kim, Won-Yong;Kang, Hyung-Lyun;Baik, Seung-Chul;Lee, Woo-Kon;Cho, Myung-Je;Rhee, Kwang-Ho
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.13 no.2
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    • pp.134-145
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    • 2010
  • Purpose: The serologic diagnosis of rotaviral infections is not commonly used in clinical practice, but is used in seroepidemiologic studies. In this study, the usefulness of Escherichia coli-expressed recombinant VP6 proteins of group A rotavirus in the serodiagnosis of rotavirus infections by ELISA was evaluated. Methods: The recombinant VP6 proteins of group A rotavirus expressed in E. coli Rosetta II strain were purified and identified. One hundred sera from 22 children (4 healthy neonates, 13 healthy children, and 5 immunocompromised children) who had serial sera samples prior to and after rotavirus infections were provided by the Gyeongsang National University Hospital, a member of the National Biobank of Korea. IgG, IgA, and IgM antibodies against rVP6 were analyzed by ELISA in all of the patients and Western blot analysis in 4 neonates. Results: ELISA tests using rVP6 proteins of group A rotavirus as antigen revealed that IgG, IgA, and IgM antibodies increased after rotaviral infections in most neonates and healthy children. IgG antibodies also increased after rotaviral infections in most immunocompromised children without an adequate increase in IgM or IgA antibodies. Western blot analysis in four neonates revealed very early IgM antibody responses, even in the sera with low optical densities in ELISA tests. Conclusion: Our study showed that ELISA using rVP6 as an antigen is a valid diagnostic tool for seroepidemiologic studies of rotavirus infections and Western blot analysis is a sensitive test in detecting IgG, IgA, and and IgM antibodies in patients with rotavirus infections.

Preoperative Detection of Hepatic Metastases from the colorectal Cancers: Comparison of Dual-phase CT scan, Mn-DPDP enhanced MRI, and combination of CT and MRI (대장암의 간 전이 진단: 이중시기 CT, Mn-DPDP 조영증강 MRI, 그리고 CT-MRI 종합 판독의 비교)

  • Shin, Kyung-Min;Kim, Jong-Yeol;Choi, Gyu-Seok;Kim, Hye-Jeong;Lee, Jong-Min;Chang, Yong-Min;Kim, Yong-Seon;Kang, Duk-Sik;Ryeom, Hun-Kyu
    • Investigative Magnetic Resonance Imaging
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    • v.9 no.2
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    • pp.109-116
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    • 2005
  • Purpose : To determine the usefulness of additional Mn-DPDP MRI for preoperative evaluation of the patients with colorectal cancers by comparison of dual-phase CT scan, Mn-DPDP enhanced MRI and combination of CT and MRI. Materials and Methods : Fifty-three colorectal cancer patients with 92 metastatic nodules underwent dualphase (arterial and portal) helical CT scan and Mn-DPDP MRI prior to surgery. The indication of MRI was presence or suspected of having metastatic lesions at CT scan and/or increased serum carcinoembryonic antigen (CEA) levels (10 ng/mL or more). The diagnosis was established by the combination of findings at surgery, intraoperative ultrasonography, and histopathologic examination. Two radiologists interpreted CT, MRI, and combination of CT-MRI at discrete sessions and evaluated each lesion for location, size, and intrinsic characteristics. The lesions were divided into three groups according to their diameter; 1cm<, 1-2 cm, and >2 cm. Diagnostic accuracy was evaluated using the alternative-free response receiver operating characteristic method. Detection and false positive rate were also evaluated. Results : In the lesions smaller than 1 cm, detection rate of combined CT-MRI was superior to CT or MRI alone (82%, p=0.036). The mean accuracy (Az values) of combined CT and MRI was significantly higher than that of CT in the lesions smaller than 2 cm (1 cm<, p=0.034; 1-2 cm, p=0.045). However, there was no significant difference between MRI and combined CT-MRI. The false positive rate of CT was higher than those of combined CT-MR in the lesions smaller than 1 cm (28%, p=0.023). Conclusion : Additional MRI using Mn-DPDP besides routine CT scan was helpful in differentiating the hepatic lesions (<2 cm) and could improve detection of the small hepatic metastases (<1 cm) from colorectal carcinoma.

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