主要目的：评价锝[99mTc]硫化胶体注射液在乳腺癌患者中进行前哨淋巴结示踪的有效性；次要目的：评价锝[99mTc]硫化胶体注射液在乳腺癌患者中进行前哨淋巴结示踪的安全性；探索性目的：探索锝[99mTc]硫化胶体注射液注射前预处理时间对检出率的影响；探索手持伽马计数器对前哨淋巴结闪烁记数阳性阈值的合理性。

开始日期2024-01-02

申办/合作机构

原子高科股份有限公司

NCT02881554 / Active, not recruitingN/AIIT

Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study

This pilot trial studies how well single photon emission computed tomography (SPECT)/computed tomography (CT) with technetium Tc-99m sulfur colloid works in measuring liver function in patients with liver cancer that has or has not spread to other place in the body who are undergoing radiation therapy or surgery. Diagnostic procedures, such as sulfur colloid SPECT/CT scans, may measure normal liver tissue before, during and after treatment and help doctors plan better treatment for liver cancer patients.

开始日期2016-12-21

申办/合作机构

University of Washington

NCT02336737 / CompletedN/A

A Pivotal, Prospective, Open-Label, Multicenter Paired Comparison Study Of SentiMag/SiennaXP And The Standard Of Care In Patients With Breast Cancer Who Are Undergoing Lymph Node Mapping As Part Of A Sentinel Node Biopsy Procedure

The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB) procedure and to summarize measures of product safety and performance.

开始日期2015-01-01

申办/合作机构

Endomagnetics Ltd.

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100 项与锝[99mTc]硫胶体相关的临床结果

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100 项与锝[99mTc]硫胶体相关的转化医学

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100 项与锝[99mTc]硫胶体相关的专利（医药）

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项与锝[99mTc]硫胶体相关的文献（医药）

2023-03-01·World Journal of Nuclear Medicine

Tagging Efficiency of 99mTc-SC Radiolabeled Alternative Gastric Emptying Meals: A Quantitative Study

Article

作者: Singh, Dhananjay Kumar ; Deswal, Satyawati ; Pathak, Anurag ; Pal, Deepak Kumar

Abstract Objective The aim of this study was to know the tagging efficiencies of technetium-99m labeled sulfur colloid (99mTc-SC) with different meals. Materials and Methods Egg white sandwiches are the gold standard for gastric-emptying scan (GES); thus, an egg white omelet labeled with 99mTc-SC is taken as a standard meal. For evaluation, we included four meals, bread and butter, instant oatmeal, idli, and chapatti, and all meals were prepared by labeling them with 99mTc-SC. After preparation, food articles were chopped with the help of a metal fork and mixed in simulated gastric fluid. Four samples were taken simultaneously from each food article and analyzed for 1 to 4hours after agitation within the centrifuge. The samples were filtered and separated from the sediments and supernatants. We analyzed the activity in each sample before and after filtration. Results The mean values of labeling efficiency in per cent of various meals were obtained. There was no significant difference in labeling stability for egg whites, chapatti, and idli meals labeled with 99mTc-SC from 1 to 4hours as their p-value (p>0.05) was insignificant. Conclusion Radiolabeled chapatti and idli with 99mTc-SC show higher labeling stability, while oatmeal and bread and butter samples show relatively low stability. Thus, for GES, chapatti and idli labeled with 99mTc-SC can be used as alternatives to eggs for vegetarian people or for those allergic to eggs.

2022-07-01·Indian Journal of Nuclear Medicine

Sentinel Node Mapping in Early Breast Cancer

Article

作者: Srivastava, Anurag ; Pandey, Ravindra Mohan ; Mathur, Sandeep ; Mishra, Piyush Ranjan ; Dhar, Anita ; Prem, Amar ; Kataria, Kamal ; Khadka, Sarada ; Seenu, Vuthaluru ; Hari, Smriti ; Suresh, Jayesh ; Kumar, Rakesh ; Bal, Chandershekhar

Purpose:Evaluation of fluorescein along with blue dye as an affordable tracer for sentinel node biopsy in comparison with technetium + methylene blue. A randomized trial was conducted with the following objectives: (1) to demonstrate that the identification of sentinel lymph node by fluorescein + methylene blue is not inferior to the identification by Tc-99 m sulfur colloid + methylene blue and (2) to evaluate the cost-effectiveness of sentinel node biopsy by above two tracers.Subjects and Methods:One-thirty patients above age 18 years presenting with early breast cancer T1, T2, N0 breast carcinoma were randomized to undergo sentinel node biopsy by either fluorescein + methylene blue or Tc-99 m sulfur colloid + methylene blue.Results:The sentinel lymph nodes were identified in 89% in Fluorescein + methylene blue group and 90.9% with Tc-99 m sulfur colloid + methylene blue group. The trial demonstrated noninferiority of fluorescein + methylene blue as compared to isotope + methylene blue with effect size = 1; 95% confidence interval- 9.54 to + 11.54. The fluorescein + methylene blue was more cost-effective than isotope guided sentinel node biopsy.Conclusion:Fluorescein-guided sentinel node biopsy is noninferior and more cost-effective than isotope-guided sentinel node biopsy.

2022-03-01·Journal of Surgical Oncology3区 · 医学

How much time is enough? Sentinel lymph node mapping time depends on the radiotracer agent

3区 · 医学

Article

作者: Berger, Adam ; Beasley, Georgia M. ; Tyler, Douglas S. ; Leddy, Margaret ; Silvestri, Caitlin ; Stroobant, Emily ; Farrow, Norma E. ; Eckhoff, Austin ; Intenzo, Charles

AbstractBackgroundIn 2014, technetium‐99m tilmanocept (TcTM) replaced technetium‐99m sulfur colloid (TcSC) as the standard lymphoscintigraphy (LS) mapping agent in melanoma patients undergoing sentinel lymph node biopsy (SLNB). The aim of this study was to examine differences in mapping time, intra‐operative identification of sentinel lymph node (SLN), and false negative rate (FNR) between patients who underwent SLNB with TcTM compared to TcSC.MethodsPatients who underwent SLNB between 2010 and 2018 were retrospectively identified. Patient demographic, tumor, and imaging data was stratified by receipt of TcSC (n = 258) or TcTM (n = 133). Student's t test and χ2 test were used to compare characteristics and outcomes.ResultsBoth cohorts were similar in demographic, primary tumor characteristics, and total number of SLN identified (TcTM 3.56 vs. TcSC 3.28, p = 0.244). TcTM was associated with significantly shorter LS mapping times (51.8 vs. 195.1 min, p < 0.01). There was no significant difference in the number of patients with positive SLN (TcTM 11.3 vs. TcSC 17.4%, p = 0.109) and the FNR was similar between both groups (TcTM 25% vs. TcSC 22%).ConclusionTcTM was associated with significantly shorter LS mapping time while identifying similar numbers of SLN. Our results support further study to ensure similar FNR and oncologic outcomes between agents.

项与锝[99mTc]硫胶体相关的新闻（医药）

2023-01-09

·信狐药迅

艾迪药业抗HIV新药艾诺米替片获批上市，哌柏西利胶囊新获批两仿制 | 新获批（1.2-1.8）

每周药品注册受理数据，分门别类呈现，一目了然。（1.2-1.8）新药上市申请药品名称企业名称分类受理号复方ACC007片江苏艾迪药业股份有限公司1CXHS2101016新药临床申请药品名称企业名称分类受理号9MW3011注射液迈威(上海)生物科技股份有限公司1CXSL22005231CXSL2200522AZD4205胶囊迪哲(江苏)医药股份有限公司1CXHL22008201CXHL22008191CXHL2200818BPI-460372片贝达药业股份有限公司1CXHL22008241CXHL2200825DZD9008片迪哲(江苏)医药股份有限公司1CXHL22008171CXHL2200816GR2001注射液重庆智翔金泰生物制药股份有限公司1CXSL2200485HS-10390片常州恒邦药业有限公司1CXHL22007841CXHL22007881CXHL2200789HY1770乳膏苏州沪云新药研发股份有限公司1CXHL22008071CXHL22008061CXHL22008051CXHL22008041CXHL22008031CXHL22008021CXHL2200801INES103注射液上海诗健生物科技有限公司1CXSL2200537KYS202002A 注射液江苏康缘药业股份有限公司1CXSL2200544LQ043H单域抗体雾化液上海洛启生物医药技术有限公司1CXSL2200548PM8002注射液普米斯生物技术(珠海)有限公司1CXSL2200516QL1706注射液齐鲁制药有限公司1CXSL2200550RC1012注射液瑞创生物技术有限公司1CXSL2200539冻干A群C群脑膜炎球菌多糖结合疫苗北京科兴中维生物技术有限公司3.3CXSL2200510麻腮风联合减毒活疫苗北京民海生物科技有限公司2.2CXSL2200511人纤维蛋白原同路生物制药有限公司3.4CXSL22005133.4CXSL2200514人源化神经生长因子抗体注射液沈阳三生制药有限责任公司1CXSL2200509重组抗PD-1全人源单抗注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2200551注射用BA1301山东博安生物技术股份有限公司1CXSL2200538注射用奥拉奇西普天境生物科技(杭州)有限公司1CXSL2200527自体淋巴细胞注射液北京康爱瑞浩生物科技股份有限公司1CXSL2200546仿制药申请药品名称企业名称分类受理号阿托伐他汀钙片通化万通药业股份有限公司4CYHS2101371氨甲环酸注射液广州绿十字制药股份有限公司3CYHS2101833广州一品红制药有限公司3CYHS2101442氨溴特罗口服溶液成都倍特得诺药业有限公司3CYHS2101595奥美沙坦酯氨氯地平片江西施美药业股份有限公司4CYHS2101137奥美沙坦酯片珠海润都制药股份有限公司4CYHS2101287苯磺贝他斯汀片江苏联环药业股份有限公司4CYHS2100008布洛芬混悬滴剂北京百奥药业有限责任公司3CYHS2101494布洛芬混悬液海南万玮制药有限公司4CYHS21017524CYHS2101751新华制药(高密)有限公司4CYHS2101619醋酸奥曲肽注射液北京市新里程医药科技有限公司4CYHS2101496福安药业集团湖北人民制药有限公司4CYHS2101444锝[99mTc]硫化胶体注射液原子高科股份有限公司3CYHL2200083地氯雷他定口服溶液海口市制药厂有限公司3CYHS2102196浙江众延医药科技有限公司3CYHS2101796哈尔滨圣泰生物制药有限公司3CYHS2101363丁酸氯维地平注射用乳剂石药集团中诺药业(石家庄)有限公司3CYHL22000873CYHL2200088对乙酰氨基酚泡腾片沈阳奥吉娜药业有限公司3CYHS2100164对乙酰氨基酚维生素C泡腾片海南涛生医药科技研究院有限公司3CYHS2100162非洛地平缓释片石家庄四药有限公司4CYHS2101621非洛地平片湖南九典制药股份有限公司3CYHS2101538酚咖片江苏万高药业股份有限公司3CYHS2101600氟康唑氯化钠注射液华夏生生药业(北京)有限公司4CYHS2101560格隆溴铵新斯的明注射液上药东英(江苏)药业有限公司3CYHL2200089江苏华泰晨光药业有限公司3CYHL2200090环孢素滴眼液艾尔健康眼药(辽宁)有限公司3CYHL2200091酒石酸美托洛尔片深圳奥萨制药有限公司4CYHS21010354CYHS2101036克林霉素磷酸酯注射液安徽省先锋制药有限公司3CYHS21013583CYHS2101359拉考沙胺注射液成都利尔药业有限公司4CYHS2101589石家庄四药有限公司4CYHS2101193磷酸特地唑胺片南京正大天晴制药有限公司4CYHS2101493北京福元医药股份有限公司4CYHS2101047硫酸镁注射液石家庄杏泽医药科技有限公司3CYHS21012973CYHS2101298硫酸沙丁胺醇雾化吸入溶液上海葆隆生物科技有限公司4CYHS21012283CYHS2101229米力农注射液华润三九(雅安)药业有限公司3CYHS21016583CYHS2101657尼洛替尼胶囊苏州特瑞药业股份有限公司4CYHS21017324CYHS2101733哌柏西利胶囊四川科伦药物研究院有限公司4CYHS21010614CYHS21010624CYHS2101063江苏奥赛康药业有限公司4CYHS2101009平衡盐溶液(供灌注用)成都青山利康药业有限公司4CYHS17003314CYHS1700330普瑞巴林胶囊亚宝药业太原制药有限公司4CYHS21014834CYHS2101484瑞戈非尼片扬子江药业集团有限公司4CYHS2101075维格列汀片深圳翰宇药业股份有限公司4CYHS2000560吸入用硫酸沙丁胺醇溶液海南斯达制药有限公司4CYHS2101136盐酸氨溴索口服溶液重庆健能医药开发有限公司3CYHS2101726江苏万高药业股份有限公司3CYHS2101561南京丰恺思药物研发有限公司3CYHS2101460盐酸氨溴索片四川美大康华康药业有限公司4CYHS2101801盐酸奥普力农注射液湖南恒生制药股份有限公司3CYHS2101178盐酸达泊西汀片广州白云山医药集团股份有限公司白云山制药总厂4CYHS20004664CYHS2000465盐酸曲美他嗪缓释片呋欧医药科技(湖州)有限公司4CYHS2101357盐酸西替利嗪口服溶液成都倍特得诺药业有限公司3CYHS21022853CYHS2102284盐酸溴己新口服液江西亿友药业有限公司3CYHS2101907盐酸左西替利嗪口服溶液浙江核力欣健药业有限公司3CYHS2101730乙酰半胱氨酸颗粒海南赛立克药业有限公司4CYHS2101933乙酰半胱氨酸泡腾片4CYHS2102136中性低钙腹膜透析液(乳酸盐)华仁药业股份有限公司3CYHS19004363CYHS1900435注射用达托霉素海南普利制药股份有限公司4CYHS21012804CYHS2101281注射用厄他培南齐鲁安替制药有限公司4CYHS2101306注射用磷酸特地唑胺南京正大天晴制药有限公司4CYHS2101263注射用硫化胶体原子高科股份有限公司3CYHL2200084左乙拉西坦片湖南嘉恒制药有限公司4CYHS2101001进口申请药品名称企业名称分类受理号Modakafusp Alfa注射液武田(中国)国际贸易有限公司1JXSL2200184Odevixibat 胶囊赛纽仕医药信息咨询(北京)有限公司2.4JXHL22003002.4JXHL2200301VAY736注射液诺华(中国)生物医学研究有限公司1JXSL2200189阿立哌唑片阿拉宾度制药有限公司5.2JYHS1900001利伐沙班片山德士(中国)制药有限公司5.2JYHS21000275.2JYHS2100028磷酸奥司他韦胶囊MSN实验室私人有限公司5.2JYHS20000165.2JYHS2000018注射用A型肉毒毒素华东医美生物科技(宁波)有限公司3.4JXSL2200179注射用TNP-2092丹诺医药(苏州)有限公司1JXHL2200288中药相关申请药品名称企业名称分类受理号复方薏薢颗粒上海中医药大学1.1CXZL2200045注：灰色字体部分结论为不批准；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

上市批准疫苗

100 项与锝[99mTc]硫胶体相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	V09DB05	DB09397

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
黑色素瘤	美国	Sun Pharmaceutical Industries, Inc.	2012-08-13
乳腺癌	美国	Sun Pharmaceutical Industries, Inc.	1978-04-17
诊断试剂	美国	Sun Pharmaceutical Industries, Inc.	1978-04-17
胃食管反流	美国	Sun Pharmaceutical Industries, Inc.	1978-04-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床3期	中国	原子高科股份有限公司	2023-12-28

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2021	N/A	-	-	99m Tc-filtered sulfur colloid (99mTc-filtered sulfur colloid)	(獵壓願廠鑰淵齋鹽積築) = The pH of the samples did not change over the time period evaluated 壓構願襯醖顧觸簾獵構 (築鬱襯範襯遞鏇築繭餘 )	积极	2021-05-18
SNMMI2021	N/A	-	-	Lidocaine HCl 1%		积极	2021-05-18
NCT02336737 (SentiMagIC, CTgov)	N/A	乳腺癌	160	SiennaXP+Technetium Tc99m Sulfur Colloid+Isosulfan blue dye	襯構糧餘鑰夢鬱築鹽顧(鹽鹽襯廠鑰構襯艱觸餘) = 餘窪遞繭醖鏇鹹觸鏇顧艱繭齋積遞憲餘壓襯簾 (選鬱淵繭糧選糧糧鏇鑰, 醖鏇鹹選觸獵醖遞膚艱 ~ 簾醖廠蓋衊願網淵廠襯) 更多	-	2020-11-03