锝[99mTc]硫胶体(Technetium Tc-99M Sulfur Colloid) - 在研适应症：黑色素瘤，乳腺癌，诊断试剂_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-

作用机制

PET imaging(正电子发射断层成像术增强剂)

治疗领域

肿瘤消化系统疾病口颌疾病+ [3]

在研适应症

黑色素瘤乳腺癌诊断试剂+ [1]

非在研适应症-

原研机构

GE Healthcare, Inc.

在研机构

原子高科股份有限公司

Sun Pharmaceutical Industries, Inc.

非在研机构

Mallinckrodt, Inc.(Old)GE Healthcare, Inc.

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

分子式S8Tc

InChIKeyFJTPHHNWVXNMEK-IEOVAKBOSA-N

CAS号-

关联

5

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 / 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.

[+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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87

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

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.

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

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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

评价

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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


NCT02336737 (SentiMagIC, CTgov)	N/A	乳腺癌	160	SiennaXP+Technetium Tc99m Sulfur Colloid+Isosulfan blue dye	製蓋顧鬱積糧願衊窪選(顧窪獵鹽構醖積鹽網鹹) = 鹽觸醖鹹夢窪選遞範憲蓋觸顧憲構餘壓糧觸鹽 (襯淵膚製簾網製觸廠鑰, 鬱顧鹽憲襯糧鹹憲艱觸 ~ 夢鏇繭顧襯膚餘醖夢鏇) 更多	-	2020-11-03