锝[99mTc]硫胶体(Technetium Tc-99M Sulfur Colloid) - 在研适应症：黑色素瘤，乳腺癌，胃食管反流_专利_临床

概要

基本信息

药物类型

小分子化药、诊断用放射药物

别名

Technetium Tc-99M Sulfur Colloid Kit、锝[99mTc]硫化胶体、An-Sulfur Colloid

+ [3]

靶点-

作用方式-

作用机制-

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Sun Pharmaceutical Industries, Inc.

原子高科股份有限公司

非在研机构

Mallinckrodt, Inc.(Old)

GE Healthcare, Inc.

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (1974-09-24),

诊断试剂

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

分子式S8Tc

InChIKeyFJTPHHNWVXNMEK-IEOVAKBOSA-N

CAS号-

关联

18

项与锝[99mTc]硫胶体相关的临床试验

CTR20234275

/ Recruiting临床3期

评价锝[99mTc]硫化胶体注射液应用于乳腺癌患者前哨淋巴结示踪的有效性和安全性：一项自身对照临床研究

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

/ TerminatedN/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

NCT02773238

/ Completed临床2期IIT

Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT)

This phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer. PET/CT imaging mid-way through treatment may be able to accurately show how well radiation therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the lung tissue are healthier than others. Based on the result of the imaging, treatment adjustments may be made to the radiation therapy to improve survival and decrease toxicity.

开始日期2016-05-20

申办/合作机构

University of Washington

[+1]

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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39

项与锝[99mTc]硫胶体相关的文献（医药）

2020-11-01·Malaysian Orthopaedic Journal

Combined Techniques of Non-invasive 99mTcBesilesomab/ 99mTc-Sulfur Colloid with Hybrid SPECT/CT Imaging in Characterising Cellulitis from Symptomatic Perimegaprosthetic Infection: A Case Report

作者: Nawi, N M ; Faisham, W I ; Wan-Sohaimi, W F ; Tagiling, N ; Mohd-Rohani, M F

Megaprosthesis is used to restore the form and function of massive skeletal defects, but it is accompanied by risks of failure, mainly due to perimegaprosthetic infection (PMI). In practice, the diagnosis of infected megaprosthesis among patients with a high index of clinical suspicion, elevated serological markers, and multiple negative or inconclusive imaging can be very challenging and poses a diagnostic conundrum to many orthopaedic surgeons. We present the case of a symptomatic 26-year-old female with large B-cell lymphoma who developed cellulitis with suspected complication of PMI 15 months post-implantation. The combination of advanced nuclear medicine imaging strategies, i.e., ^99mTc-besilesomab/^99mTc-sulfur colloid scintigraphy with hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) scanning helps to characterise and delineate both infections. Invasive procedures such as joint aspiration and biopsy were avoided, and the patient was successfully treated with antibiotics. Hence, we report a case where advanced imaging modalities were decisive in the investigation of PMI.

2018-03-01·Journal of Medical Imaging and Radiation Sciences

Effect of Topical Anesthetic Cream on Pain During Periareolar Injection of Technetium Tc99m Sulfur Colloid for Sentinel Lymph Node Biopsy in Breast Cancer: A Randomized Control Trial

Article

作者: Bryson-Campbell, Mikelle ; Canning, Sarah ; Suryavanshi, Rajeev

BACKGROUNDInjection of Tc99m to localize nodes for sentinel lymph node biopsy is reported by patients as very painful. The purpose of this study was to determine if anesthetic cream reduces pain associated with periareolar injection of Tc99m and to help elucidate conflicting literature regarding the efficacy of anesthetic cream for this procedure.METHODSA randomized, double-blind, placebo-controlled methodology was used for adult females with breast cancer undergoing periareolar injection of Tc99m for sentinel lymph node biopsy. Pain levels were compared using anesthetic cream (2.5% lidocaine/2.5% prilocaine) vs. placebo. Patient exclusion criteria included use of opioids or adjuvant pain medication or injecting Tc99m the day before surgery. The Numerical Rating Scale was used to assess pain levels immediately after the injections.RESULTSComparing 23 experimental and 26 control patients, there was no significant difference between the experimental (median = 4) and the control group (median = 5) on level of pain experienced U= 0.492, P > .05.CONCLUSIONSThe experimental group had a slightly lower median pain score; however, there was no statistically significant difference between those who used the cream compared with those who used a placebo, supporting the conclusion that anesthetic cream does not reduce pain during Tc99m injections. This study adds to the current literature to provide a stronger position that there is no benefit to using anesthetic cream for this procedure.

2017-12-01·Journal of Surgical Oncology

Tc‐99m tilmanocept versus Tc‐99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial

Article

作者: Hosseini, Ava ; Wallace, Anne M. ; Unkart, Jonathan T.

IntroductionNo prior trials have compared sentinel lymph node (SLN) identification outcomes between Tc‐99m tilmanocept (TcTM) and Tc‐99m sulfur colloid (TcSC) in breast cancer (BC).MethodsWe report on the secondary outcomes from a randomized, double‐blinded, single surgeon clinical trial comparing post‐injection site pain between TcTM and TcSC. Patients were randomized to receive a preoperative single, peritumoral intradermal injection of TcTM or TcSC. The number of total, “hot”, and blue nodes detected and removed were compared between groups.ResultsFifty‐two (27‐TcSC and 25‐TcTM) patients were enrolled and underwent definitive surgical treatment. At least one “hot” SLN was detected in all patients. Three (5.8%) patients had a disease positive‐SLN. The total number of SLNs removed was 61 (mean 2.26 (standard deviation (SD) 0.90)) in the TcSC group and 54 (mean 2.16 (SD 0.90)) in the TcTM group, P = 0.69. The total number of “hot” nodes in the TcSC group was 1.96 (SD 0.76) compared to 2.04 (SD 0.73) in the TcTM group, P = 0.71.ConclusionsThe number of identified SLNs did not differ significantly between TcTM and TcSC. Given that no significant technical advantages exist between the two agents, surgeons should choose a radiopharmaceutical based on cost and side effect profile.

1

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
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
浸润性乳腺癌	临床3期	中国	原子高科股份有限公司	2024-01-02

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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)	(襯蓋夢選選淵鹽襯鹽觸) = The pH of the samples did not change over the time period evaluated 醖觸鬱衊憲淵積繭糧選 (蓋壓築膚獵窪獵觸糧繭 )	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	鬱廠糧製艱襯糧製壓選(積鬱餘選夢觸淵鬱願淵) = 衊膚網壓積範願構鹹醖積淵壓繭簾淵願築襯構 (鑰鹽獵選遞衊衊廠鹹繭, 網憲壓獵糧鬱願網製窪 ~ 壓壓膚廠構蓋夢憲艱築) 更多	-	2020-11-03
NCT02419807 (CTgov)	N/A	乳腺癌	102	Axillary Lymph Node Biopsy+Technetium Tc-99m Sulfur Colloid	構網網遞鏇繭齋鹹廠遞(網鹽衊範蓋選製醖夢遞) = 遞餘網顧艱鹽夢積醖淵餘齋鏇齋衊淵窪鹹夢獵 (鏇壓願餘範獵觸簾壓製, 積繭醖淵願廠淵糧觸醖 ~ 廠窪衊鹽蓋鹽醖蓋網艱) 更多	-	2020-10-22
NCT00070317 (CTgov)	N/A	腺鳞癌 \| 宫颈鳞状细胞癌 \| 子宫颈腺癌	102	Sentinel Lymph Node Biopsy+Technetium Tc-99m Sulfur Colloid+Methylene Blue+Isosulfan Blue	(醖觸遞膚範觸廠網範醖) = 襯鹽積鏇鑰選顧範顧蓋構衊蓋窪網積範襯窪憲 (糧積鹹艱範膚醖觸積築, 願願鹽鹹製蓋製繭構觸 ~ 齋膚簾齋膚糧顧壓鬱構) 更多	-	2017-10-03
NCT01276054 (CTgov)	临床2期	乳腺癌淋巴水肿 \| 复发性乳腺癌	4	lymphedema management+technetium Tc 99m sulfur colloid+methylene blue (SNB Plus ARM or ALND (+/- SNB) Plus ARM)	積廠鬱壓觸淵衊淵窪壓(鹹艱築構繭襯襯夢選鬱) = 餘製鬱膚願簾遞窪齋餘繭齋簾膚繭鑰襯襯獵鹹 (網襯窪願醖範憲淵夢觸, 願淵遞選鑰鹽積夢齋糧 ~ 構網淵糧淵醖壓蓋獵衊) 更多	-	2014-08-01
NCT01276054 (CTgov)	临床2期	乳腺癌淋巴水肿 \| 复发性乳腺癌	4	bioimpedance spectroscopy+technetium Tc 99m sulfur colloid+methylene blue (SNB or ALND (+/- SNB))	積廠鬱壓觸淵衊淵窪壓(鹹艱築構繭襯襯夢選鬱) = 簾鹽窪醖鬱餘簾艱選醖繭齋簾膚繭鑰襯襯獵鹹 (網襯窪願醖範憲淵夢觸, 衊製壓網願齋衊積築願 ~ 鬱衊顧觸餘鏇鏇繭齋襯) 更多	-	2014-08-01