更新于：2024-11-21

99mTc-Sulesomab

更新于：2024-11-21

概要

研发状态

概要

基本信息

药物类型

抗体偶联核素、诊断用放射药物

别名

99mTc-Sulesomab、ImmuRAID MN3 Tc 99m、Immunoglobulin G1 (mouse monoclonal IMMU-MN3 Fab' fragment gamma-chain anti-human NCA-90 granulocyte cell antigen), disulfide with mouse monoclonal IMMU-MN3 light chain

+ [3]

靶点

CEACAM6

作用机制

CEACAM6抑制剂(癌胚抗原相关细胞粘附分子6抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Australian Nuclear Science & Technology Organisation

非在研机构

Immunomedics GmbH

最高研发阶段批准上市

首次获批日期

欧盟 (1997-02-14),

糖尿病足溃疡骨髓炎

最高研发阶段(中国)-

特殊审评-

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结构

使用我们的ADC技术数据为新药研发加速。

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关联

项与 99mTc-Sulesomab 相关的临床试验

EUCTR2017-000162-30-FR / Unknown status临床4期IIT

Place de la scintigraphie au 99mTc-Leukoscan® dans la prise en charge diagnostique des suspicions d’endocardite infectieuse sur matériels - PLEIM

开始日期2017-03-30

申办/合作机构

Hospices Civils de Lyon

100 项与 99mTc-Sulesomab 相关的临床结果

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100 项与 99mTc-Sulesomab 相关的转化医学

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100 项与 99mTc-Sulesomab 相关的专利（医药）

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项与 99mTc-Sulesomab 相关的文献（医药）

2021-12-20·Journal of Investigational Allergy and Clinical Immunology3区 · 医学

English

3区 · 医学

Article

作者: Frans, G ; Breynaert, C ; Jacobs, J ; Coorevits, L ; Verscuren, R ; Schrijvers, R

2021-02-01·BMJ Military Health4区 · 医学

Value of antigranulocyte scintigraphy with Tc-99m-sulesomab in diagnosing combat-related infections of the musculoskeletal system

4区 · 医学

Article

作者: Willy, C ; Vogt, D ; Stichling, M ; Mai, A ; Starke, M ; Loessel, Christian

AimCombat-related extremity injuries are regularly associated with long-term complications such as chronic infection, especially osteomyelitis. Clinical examination and laboratory parameters do not usually allow reliable diagnosis. In contrast, imaging techniques enable constructive assertions to be made about the location and extent of an infection of the peripheral musculoskeletal system. The aim of this study was therefore to determine the diagnostic reliability of three-phase bone scanning and antigranulocyte scintigraphy using Tc-99m-sulesomab (Leukoscan) in the diagnostic clarification of infections associated with combat-related extremity injuries.MethodsTwenty-seven male patients (mean age 33.9 years) with suspected combat-associated infections of the extremities were included in this retrospective analysis. All patients underwent three-phase bone scanning using Tc-99m-HDP followed by antigranulocyte scintigraphy with Tc-99m-sulesomab. In 26 of the 27 patients, a CT scan of affected limb was obtained, where the secondary fusion with single photon emission CT data set was possible. The diagnostic reliability of imaging techniques was validated against microbiological samples obtained during surgery and used as gold standard.ResultsThree-phase bone scanning yielded a positive result in all patients, with 18 scans classified as true positive (TP) and nine scans as false positive (FP). This produced a sensitivity of 100%, a specificity of 0% and a positive predictive value (PPV) of 67%. Antigranulocyte scintigraphy recognised 13 patients as TP, 1 patient as FP, 8 patients as true negative (TN) and 5 patients as false negative (FN), which gave a sensitivity of 72%, a specificity of 88%, a PPV of 93%, a negative predictive value (NPV) of 62% and an accuracy of 78%. CT recognised in 7 cases a TP result, in 3 cases an FP, in 5 cases a TN and in 11 cases an FN result. This produced a sensitivity of 39%, a specificity of 63%, a PPV of 70%, an NPV of 31% and an accuracy of 46%.ConclusionsThree-phase bone scanning did not deliver any diagnostic benefit, since no result was able to differentiate unequivocally between infection-related and reactive changes. Antigranulocyte scintigraphy using Tc-99m-sulesomab represented a highly suitable technique for diagnostically clarifying combat-related infections of the extremities. It is superior to CT in sensitivity, specificity, PPV, NPV and accuracy.

2016-12-01·The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of...4区 · 医学

Targeting osteomyelitis with complete [99mTc]besilesomab and fragmented [99mTc]sulesomab antibodies: kinetic evaluations.

4区 · 医学

Article

作者: Luster, Markus ; Kemke, Bendix ; Reize, Patrik ; Gratz, Stefan ; Kampen, Wim U ; Höffken, Helmut

BACKGROUNDThe aim of this retrospective study was to compare the targeting of "pure" osteomyelitis (i.e., without surrounding soft tissue infection) by directly 99mTc-labelled complete immunoglobulin G (IgG) monoclonal antibody (MAb) ([99mTc]besilesomab) and by directly 99mTc-labelled fragment antigen-binding (FAb) MAb ([99mTc]sulesomab) in relation to their kinetic fate. A total of 73 patients with "pure" osteomyelitis were examined with [99mTc]besilesomab, (Scintimun®, IBA/CIS bio international, Saclay, France; N.=38) and [99mTc]sulesomab (LeukoScan®, Immunomedics Inc., Morris Plains, NJ, USA; N.=35).METHODSKinetic data were deduced from whole-body and single-photon emission computed tomographic scans, performed 10 minutes to 24 hour p.i. (region-of-interest technique [ROI]).RESULTSIn targeting "pure" osteomyelitis, sensitivities at 1-4 hours were found to be higher for [99mTc]sulesomab (44% and 80% for [99mTc]besilesomab and [99mTc]sulesomab, respectively) but at significantly lower target/background (T/B) ratios than with [99mTc]besilesomab (1.8±0.3 versus 1.4±0.5 for [99mTc]besilesomab and [99mTc]sulesomab respectively; P<0.01). With [99mTc]besilesomab, there was a continuous osteomyelitis uptake over 24 hours, whereas with [99mTc]sulesomab, the maximal uptake occurred mostly within 1-4 hours, with subsequent clearance being slower for antigen-bound activity than for nonspecific background. Hence, diagnosis was possible mostly after 4h with [99mTc]sulesomab but often not before 24 hours with [99mTc]besilesomab, the later increasing significantly (P<0.01) in sensitivity (87% and 84% for [99mTc]besilesomab and [99mTc]sulesomab, respectively).CONCLUSIONSThese results show that the higher sensitivity of [99mTc]sulesomab in osteomyelitis targeting at earlier p.i. times does not rely on an increased antibody uptake but on a more rapid clearance of nonspecific background activity due to faster metabolism and excretion. Intact [99mTc]besilesomab show a slow, continuous uptake, leading to higher T/B at later p.i. times, often beyond the imaging possibilities of 99mTc.

100 项与 99mTc-Sulesomab 相关的药物交易

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