1.Feasibility of Radioembolization With Yttrium-90 Resin Microspheres Without Lung Shunt Fraction Measurement for Intrahepatic Cholangiocarcinoma
Myungsu LEE ; Do Hoon KIM ; Minseok SUH ; Jin Chul PAENG ; Hyo-Cheol KIM
Korean Journal of Radiology 2026;27(3):244-251
Objective:
To evaluate the feasibility of streamlined radioembolization using yttrium-90 resin microspheres without lung shunt fraction (LSF) assessment in patients with intrahepatic cholangiocarcinoma (ICC).
Materials and Methods:
This single-center retrospective study included 23 patients with ICC who underwent radioembolization using resin microspheres (SIR-Spheres; SIRTEX, Woburn, MA, USA) without LSF measurement between April 2022 and April 2025.Eligibility criteria, based on prior institutional data, included a target tumor size less than 10 cm, absence of hepatic vein invasion and intratumoral dysmorphic vessels, and an institutional waiting time exceeding one week for macroaggregated albumin scintigraphy. All patients had at least one follow-up imaging study. Radiation activity was prescribed according to tumor location, liver function, and clinical setting, using both single-compartment and multi-compartment dosimetry under the assumptions of a 5% LSF and a tumor-to-normal (TN) ratio of 3. Post-treatment yttrium-90 PET/CT dosimetry was performed in 12 patients. Treatment-related toxicity, tumor response, and local tumor progression-free survival were analyzed.
Results:
The median administered activity was 1.43 GBq (interquartile range, 0.89–2.15). The median mean absorbed dose to the perfused tissue was 147 Gy, and the median tumor absorbed dose (TAD) was 339 Gy, assuming a TN ratio of 3. Posttreatment PET/CT analysis demonstrated a median TAD of 371 Gy and a median TN ratio of 4.7. No patient developed symptomatic radiation pneumonitis. Best tumor response was partial response in 52% of patients and stable disease in 48%. Local tumor progression-free survival rates at six months, one year, and two years were 95.2%, 81.1%, and 81.1%, respectively.
Conclusion
Streamlined radioembolization without LSF assessment appears feasible and may represent a practical alternative to conventional multi-step workflows in patients with ICC measuring less than 10 cm.
2.Comparison of the Advisory Committees for the Pharmaceutical Regulatory Authorities of the United States, the European Union and the Republic of Korea
Minseok KIM ; Minseo KANG ; Jangik I. LEE
Korean Journal of Clinical Pharmacy 2025;35(4):243-256
Background:
Regulatory agencies operate their own advisory committee with external experts to address complex scientific issues in the approval of pharmaceutical products. However, each advisory committee operates very differently. Hence, the authors per-formed a comprehensive gap analysis among the committees operated by Food and Drug Administration (FDA), European Medicines Agency (EMA) and Ministry of Food and Drug Safety (MFDS).
Methods:
The regulations, guidelines, minutes and reports on advisory committees were retrieved from the websites of FDA, EMA and MFDS. A gap analysis comparing the advisory committeesof each regulatory authority was performed, including the disclosure of information and meeting procedures, and conflict-of-interest policies.
Results:
Substantial differences were found among the advisory committees in the strictness of conflict-of-interests and the transparency of meeting details. Whereas FDA and EMA disclose the detailed curriculum vitae of each committee member, MFDS does only names and majors. Whereas FDA live-streams each meeting and publishes the transcript of all dialogues by each member, EMA and MFDS release only anonymized summary minutes without live broadcasts. Whereas FDA and EMA require members to disclose their financial interests, MFDS merely requires signing a statement that confirms no conflict-of-interest.
Conclusions
Compared with Advisory Committee of FDA and Scientific Committee of EMA, the Central Pharmaceutical Affairs Advisory Committee (CPAAC) of MFDS appears to require substantial improvements in the disclosure of conflict-of-interests and the transparency ofmeeting details. This gap analysis will likely serve as a basis for policy discussions to improve the credibility of CPAAC.
3.Neovascularization in Outer Membrane of Chronic Subdural Hematoma : A Rationale for Middle Meningeal Artery Embolization
Hyun KIM ; Yoori CHOI ; Youngsun LEE ; Jae-Kyung WON ; Sung Ho LEE ; Minseok SUH ; Dong Soo LEE ; Hyun-Seung KANG ; Won-Sang CHO ; Gi Jeong CHEON
Journal of Korean Neurosurgical Society 2024;67(2):146-157
Objective:
: Chronic subdural hematomas (cSDHs) are generally known to result from traumatic tears of bridging veins. However, the causes of repeat spontaneous cSDHs are still unclear. We investigated the changes in vasculature in the human dura mater and outer membrane (OM) of cSDHs to elucidate the cause of their spontaneous repetition.
Methods:
: The dura mater was obtained from a normal control participant and a patient with repeat spontaneous cSDHs. The pathological samples from the patient included the dura mater and OM tightly adhered to the inner dura. The samples were analyzed with a particular focus on blood and lymphatic vessels by immunohistochemistry, 3-dimensional imaging using a transparent tissue clearing technique, and electron microscopy.
Results:
: The dural border cell (DBC) layer of the dura mater and OM were histologically indistinguishable. There were 5.9 times more blood vessels per unit volume of tissue in the DBC layer and OM in the patient than in the normal control. The DBC layer and OM contained pathological sinusoidal capillaries not observed in the normal tissue; these capillaries were connected to the middle meningeal arteries via penetrating arteries. In addition, marked lymphangiogenesis in the periosteal and meningeal layers was observed in the patient with cSDHs.
Conclusion
: Neovascularization in the OM seemed to originate from the DBC layer; this is a potential cause of repeat spontaneous cSDHs. Embolization of the meningeal arteries to interrupt the blood supply to pathological capillaries via penetrating arteries may be an effective treatment option.
4.Phase 1 Study of No-Carrier Added 177Lu-DOTATATE (SNU-KB-01) in Patients with Somatostatin Receptor–Positive Neuroendocrine Tumors: The First Clinical Trial of Peptide Receptor Radionuclide Therapy in Korea
Hyun Gee RYOO ; Minseok SUH ; Keon Wook KANG ; Dae-Won LEE ; Sae-Won HAN ; Gi Jeong CHEON
Cancer Research and Treatment 2023;55(1):334-343
Purpose:
To provide a wider choice of treatment opportunities for patients with neuroendocrine tumor (NET) in Korea, we have conducted a phase 1, open-label, single-arm, dose-escalation study of SNU-KB-01, a no-carrier added (NCA) 177Lu-labeled DOTATATE.
Materials and Methods:
Seven patients with inoperable, progressive, metastatic, or locally advanced, somatostatin receptor-positive NET with Ki67 index ≤ 20% were enrolled according to the rolling six design. The study consisted of two cohorts to receive 4 cycles of SNU-KB-01 every 8 weeks for the first dose of 5.55 GBq (n=3) and 7.40 GBq (n=4). We assessed the incidence of dose-limiting toxicity (DLT) and adverse event, absorbed dose of kidneys and bone marrow, and objective tumor response.
Results:
Seven patients completed 4 cycles (21.3-30.1 GBq total dose) of SNU-KB-01. The mean absorbed doses to kidneys and bone marrow were 0.500 mGy/MBq and 0.053 mGy/MBq, respectively, and the total body effective dose was 0.115 mSv/MBq. No DLT was observed and the maximum tolerated dose was 7.40 GBq/cycle. Grade 3 thrombocytopenia occurred in one patient, but no other grade 3 or 4 major hematologic or renal toxicity was observed. The best objective response to SNU-KB-01 was partial response. Overall response rate was 42.9% and disease control rate was 85.7%.
Conclusion
Treatment with 4 cycles of SNU-KB-01 was well tolerated and resulted in control of disease in most of the patients. Our results indicate SNU-KB-01, an NCA 177Lu-labeled DOTATATE, as a potentially safe and efficacious treatment option for NET patients in Korea.
5.Epigenetic Regulation of the Expression of T Cell Stimulatory and Inhibitory Factors by Histone H3 Lysine Modification Enzymes and Its Prognostic Roles in Glioblastoma
Sang Hyuk LEE ; Seung Hwan KIM ; Taek Min NAM ; Ji Hwan JANG ; Kyu Hong KIM ; Young-Sam LEE ; Minseok S. KIM ; Mee-Seon KIM ; Sung Yup JIN ; Moonok LEE ; Sung-Hun LEE ; Young Zoon KIM
Journal of Korean Medical Science 2023;38(33):e258-
Background:
This study aimed to identify the specific T cell co-stimulatory and co-inhibitory factors that play prognostic roles in patients with glioblastoma. Additionally, the unique histone H3 modification enzymes that regulate the expression levels of these specific costimulatory and co-inhibitory factors were investigated.
Methods:
The medical records of 84 patients newly diagnosed with glioblastoma at our institution from January 2006 to December 2020 were retrospectively reviewed.Immunohistochemical (IHC) staining for T cell co-stimulatory factors (CD27, CD28, CD137, OX40, and ICOS), T cell co-inhibitory factors (CTLA4, PD1, PD-L1, TIM3, and CD200R), and histone H3 lysine modification enzymes (MLL4, RIZ, EZH1, NSD2, KDM5c, JMJD1a, UTX, and JMJD5) was performed on archived paraffin-embedded tissues obtained by biopsy or resection. Quantitative real time-polymerase chain reaction (qRT-PCR) was performed for specific factors, which demonstrated causal relationships, in order to validate the findings of the IHC examinations.
Results:
The mean follow-up duration was 27.5 months (range, 4.1–43.5 months). During this period, 76 patients (90.5%) died, and the mean OS was 19.4 months (95% confidence interval, 16.3–20.9 months). Linear positive correlations were observed between the expression levels of CD28 and JMJD1a (R2 linear = 0.982) and those of CD137 and UTX (R2 linear = 1.528). Alternatively, significant negative correlations were observed between the expression levels of CTLA4 and RIZ (R2 linear = −1.746) and those of PD-L1 and EZH1 (R2 linear = −2.118); relationships were confirmed by qRT-PCR. In the multivariate analysis, increased expression levels of CD28 (P = 0.042), and CD137 (P = 0.009), and decreased expression levels of CTLA4 (P = 0.003), PD-L1 (P = 0.020), and EZH1 (P = 0.040) were significantly associated with longer survival.
Conclusion
These findings suggest that the expression of certain T cell co-stimulatory factors, such as CD28 and CD 137, and co-inhibitory factors, such as CTLA4 and PD-L1 are associated with prognosis of glioblastoma patients.
6.Incidence of acute cholecystitis underwent cholecystectomy in incidence dialysis patients: a nationwide population-based cohort study in Korea
Hanlim CHOI ; Soon Kil KWON ; Joung-Ho HAN ; Jun Su LEE ; Gilwon KANG ; Minseok KANG
Kidney Research and Clinical Practice 2022;41(2):253-262
Patients on dialysis have numerous gastrointestinal problems related to uremia, which may represent concealed cholecystitis. We investigated the incidence and risk of acute cholecystitis in dialysis patients and used national health insurance data to identify acute cholecystitis in Korea. Methods: The Korean National Health Insurance Database was used, with excerpted data from the insurance claim of the International Classification of Diseases code of dialysis and acute cholecystitis treated with cholecystectomy. We included all patients who commenced dialysis between 2004 and 2013 and selected the same number of controls via propensity score matching. Results: A total of 59,999 dialysis and control patients were analyzed; of these, 3,940 dialysis patients (6.6%) and 647 controls (1.1%) developed acute cholecystitis. The overall incidence of acute cholecystitis was 8.04-fold higher in dialysis patients than in controls (95% confidence interval, 7.40–8.76). The acute cholecystitis incidence rate (incidence rate ratio, 23.13) was especially high in the oldest group of dialysis patients (aged ≥80 years) compared with that of controls. Dialysis was a significant risk factor for acute cholecystitis (adjusted hazard ratio, 8.94; 95% confidence interval, 8.19–9.76). Acute cholecystitis developed in 3,558 of 54,103 hemodialysis patients (6.6%) and in 382 of 5,896 patients (6.5%) undergoing peritoneal dialysis. Conclusion: Patients undergoing dialysis had a higher incidence and risk of acute cholecystitis than the general population. The possibility of a gallbladder disorder developing in patients with gastrointestinal problems should be considered in the dialysis clinic.
7.Effect of Attitude Toward Suicide on Suicidal Behavior: Based on the Korea National Suicide Survey
Min Ji KIM ; Hyunju LEE ; Daun SHIN ; Minseok HONG ; Sang Jin RHEE ; Jong-Ik PARK ; Yong Min AHN
Psychiatry Investigation 2022;19(6):427-434
Objective:
Suicide is a complex phenomenon; therefore, it should be approached in light of sociocultural perspectives and the general attitude toward suicide. This study aimed to extract factors from the Attitude Toward Suicide Scale (ATTS) and investigate the relationship between attitudes toward suicide and suicidal behavior (i.e., suicidal idea, plan, and attempt) by using a representative sample of Korean adults.
Methods:
Three thousand Koreans aged 19 to 75 years were surveyed cross-sectionally in 2013 and 2018. The data collected were subjected to exploratory factor analysis. Extracted attitude factors were compared using a suicidal behavior continuum. Univariate and multivariate logistic models were constructed to compare the association between attitude factors and suicidal behaviors.
Results:
Among the participants, 477 (15.9%) experienced suicidal idea only, 85 (2.8%) had a suicidal plan without attempt, and 58 (1.9%) attempted suicide. Four meaningful factors were extracted from the factor analysis: “permissiveness,” “unjustified behavior,” “preventability/readiness to help,” and “loneliness.” “Permissiveness,” “unjustified behavior,” and “loneliness” factors showed significant trends across the suicidal behavior continuum. Permissive attitude toward suicide increased the odds of suicidal idea, suicidal plan, and suicide attempt (adjusted odds ratio [aOR]=1.49, 95% confidence interval [CI]=1.25–1.79; aOR=2.79, 95% CI=1.84–4.25; aOR=2.67, 95% CI=1.65–4.33), while attitude toward suicide as unjustified behavior decreased the odds of suicidal ideation and attempt (aOR=0.79, 95% CI=0.67–0.94; aOR=0.64, 95% CI=0.42–0.99).
Conclusion
A significant association was found between attitude toward suicide and suicidal behaviors. Attitude toward suicide is a modifiable factor that can be used to develop prevention policies.
8.Exploratory evaluation of the role of cardiac troponin on the clinical outcome of patients visiting emergency department with or without chronic kidney disease
Minseok SONG ; Eun-Jin KANG ; Taerim KIM ; Jong Eun PARK ; Gun Tak LEE ; Hee YOON ; Sung Yeon HWANG ; Won Chul CHA ; Tae Gun SHIN ; Min Seob SIM ; Ik Joon JO ; Jin-Ho CHOI
Journal of the Korean Society of Emergency Medicine 2021;32(6):548-560
Objective:
Elevated levels of cardiac troponin in chronic kidney disease (CKD) patients admitted to the emergency department (ED) is not well understood and is often ignored. This study aimed to investigate the impact of cardiac troponin I (TnI) levels on the clinical outcome of patients visiting the ED with or without CKD.
Methods:
In this retrospective single-center cohort study, we enrolled patients visiting the ED without a diagnosis of coronary artery disease (CAD). Elevated cardiac TnI was defined as being ≥99th percentile of the normal population (Siemens ADVIA Centaur TnI-Ultra≥0.040 ng/mL). The clinical outcomes of patients with CKD stage≤2 and CKD stage ≥3 were compared. The primary endpoint was the 180-day all-cause death, including cardiovascular and non-cardiovascular deaths.
Results:
Among a total of 30,472 patients (median age, 61 years; male sex, 54.3%), elevated TnI was found in 4,377 patients (14.4%). There were 3,634 deaths (11.9%) including 584 cardiovascular (1.9%) and 3,050 non-cardiovascular deaths (10.0%). The risk of all-cause death increased in patients with elevated TnI in both CKD stage≤2 (hazard ratio [HR], 2.1; 95% confidence interval [CI], 1.9-2.3) and CKD stage≥3 (HR, 1.5; 95% CI, 1.4-1.7), and so did the risks of cardiovascular and non-cardiovascular death (HR, 1.2-4.7) (P<0.05, all). The association of elevated TnI with death risk was consistent in multivariate analyses and in most clinical subgroup analyses.
Conclusion
Elevated TnI was associated with higher 180-day mortality irrespective of renal function among patients visiting the ED without documented CAD. CKD patients visiting the ED with elevated TnI may warrant additional evaluation or careful follow-up even without the presence of CAD.
10.Usefulness of Allogenic Acellular Dermal Matrix for Prevention of Scalp Depressio
Min-Gyu CHOI ; Minseok LEE ; Sang-Jun SUH ; Yoon-Soo LEE ; Jeong-Ho LEE ; Dong-Gee KANG
Korean Journal of Neurotrauma 2020;16(2):174-180
Objective:
Burr hole trephination is a common treatment for chronic subdural hematoma, intracranial hematoma, and intraventricular hematoma due to its effective drainage of hematoma, minimal invasiveness and short operation time. However, cosmetic complications such as scalp depression can occur. The aim of this study was to evaluate the usefulness of an allogenic acellular dermal matrix (ADM) to prevent scalp depression at the burr hole site.
Methods:
A retrospective analysis was performed with 75 cases in 66 patients who were treated with burr hole trephination from January 2018 to December 2019. These cases divided into 2 groups; based on the method used to cover the burr hole site: Gelfoam packing only (GPO) and ADM. The degree of the scalp depression was measured from the more recent follow-up brain computed tomography scan.
Results:
There was a significant difference in the degree of scalp depression between GPO and ADM groups (p=0.003). No significant correlation between patient's age and the degree of scalp depression (GPO: p=0.419, ADM: p=0.790). There were no wound infection complication in either group.
Conclusion
ADM is a suitable material to prevent scalp depression after burr hole trephination.

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