在感染成像中平衡创新和可访问性:从Tc-besilesomab悖论中吸取教训
Océane Mesnilgrante1,2, Typhanie Ladrière1,2, Noémie Allouche1,2
1UNICAEN Department of Nuclear Medicine, CHU Caen Normandie, Normandie Université, Avenue de La Côte de Nacre, CS 30001, 14000, Caen, France.
EJNMMI radiopharmacy and chemistry
|February 7, 2026
概括
恢复[99mTc]Tc-besilesomab感染成像的使用需要创新. 需要新的定量HAMA测试和欧洲指南,以平衡患者安全与诊断可用性.
科学领域:
- 核医学是一种核医学.
- 感染成像的成像学
- 免疫性打印图像的使用方法.
背景情况:
- 核医学技术如[18F]FDG PET/CT,放射性标记白血细胞 (WBC) 扫描和[99mTc]Tc-besilesomab扫描对于感染诊断至关重要.
- [99mTc]Tc-besilesomab提供比体外WBC标记更简单的感染成像,但需要人类抗老鼠抗体 (HAMA) 测试以防止反应.
- 哈马检测对于患者安全至关重要,但可能会限制[99mTc]Tc-besilesomab成像的使用.
研究的目的:
- 为了应对由于监管和方法因素导致的[99mTc]Tc-besilesomab免疫印术的难题.
- 探索欧洲IVDR变化对HAMA测试的影响及其对感染成像的影响.
- 倡导解决方案,平衡患者安全与核医学诊断工具的可访问性.
主要方法:
- 审查欧洲体外诊断的监管变化 (IVDR 2017/746).
- 分析从定量到定性HAMA测试的转变及其解释.
- 检查报告的积极HAMA快速测试的增加和潜在的患者从成像中排除.
主要成果:
- 欧洲IVDR框架和定量HAMA分析的市场撤销使HAMA测试复杂化.
- 定性快速HAMA测试可能会导致错误阳性增加,可能会使患者从[99mTc]Tc-besilesomab成像中排除.
- 这种监管和方法的转变矛盾地限制了旨在改善它的工具的可访问性.
结论:
- 恢复[99mTc]Tc-besilesomab免疫印的可用性需要技术和监管方面的进步.
- 开发定量点的护理HAMA测定和促进替代标记物 (人性化,以纳米体为基础) 是关键.
- 需要协调的欧洲指导方针,以确保患者的安全,同时保持感染成像诊断的可用性.
关键词:
人类抗老鼠抗体 (HAMA)感染成像的成像学无线电免疫诊断的诊断.放射性药物 放射性药物 放射性药物[18F]FDG PET/CT PET/CT PET/CT/CT/CT [18F]FDG PET/CT/CT PET/CT/CT [18F]FDG PET/CT/CT[99mTc]Tc-besilesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablesomablessomablessomablessomablessomablessomablessomablessomablessomablessomablessom
相关概念视频
02:58Balancing Redox Equations
62.3K
Electrochemistry is the science involved in the interconversion of electrical and chemical reactions. Such reactions are called reduction-oxidation, or redox reactions. These important reactions are defined by changes in oxidation states for one or more reactant elements and include a subset of reactions involving the transfer of electrons between reactant species. Electrochemistry as a field has evolved to yield sufficient insights on the fundamental principles of redox chemistry and multiple...
62.3K
01:15Equilibrium and Balance
6.7K
The inner ear assumes dual functionalities of auditory perception and equilibrium maintenance. The vestibule is the organ responsible for balance. This organ contains mechanoreceptors, specifically hair cells, endowed with stereocilia, which aid in deciphering information regarding the position and motion of our heads. Two intrinsic components, the utricle and saccule, help perceive head position, while the semicircular canals track head movement. Neurological messages initiated in the...
6.7K
01:19Energy Balance
1.2K
The human body gets energy from the three macronutrients: carbohydrates, proteins, and fats. Energy is released when the chemical bonds in the organic compounds present in the food are broken down. The energy content of food is measured in kilocalories (kcal), defined as the amount of heat required to raise the temperature of one kilogram of water by one degree Celsius. This value is determined by measuring the temperature change of the water surrounding a calorimeter after the complete...
1.2K
01:18Respiratory Regulation of Acid-Base Balance
1.8K
Respiratory compensation is a vital physiological process that stabilizes blood plasma pH by regulating the partial pressure of carbon dioxide (PCO2), a key determinant of pH levels. Most carbon dioxide in the blood dissolves and converts into carbonic acid (H2CO3). It dissociates into hydrogen ions (H+) and bicarbonate ions (HCO3⁻). There is also an inverse relationship between PCO2 and pH.
When carbon dioxide levels increase in the blood, more H+ and HCO3⁻ are...
When carbon dioxide levels increase in the blood, more H+ and HCO3⁻ are...
1.8K
01:29Disorder of Water Balance
2.6K
Water balance disorders are medical conditions that occur when there is a deviation from the body's water volume or osmolarity, disrupting normal homeostasis and leading todehydration, hypotonic hydration, hyperhydration, edema, or water intoxication.
Dehydration
Dehydration occurs when the body loses fluids (particularly water).
Causes:
The major causes of dehydration include excessive sweating, fever, vomiting, diarrhea, and diuresis.
Signs and Symptoms:
Symptoms primarily include intense...
Dehydration
Dehydration occurs when the body loses fluids (particularly water).
Causes:
The major causes of dehydration include excessive sweating, fever, vomiting, diarrhea, and diuresis.
Signs and Symptoms:
Symptoms primarily include intense...
2.6K
01:25Acid-Base Balance
2.6K
The human body maintains a narrow pH range regulated through acid-base balance. This balance is crucial as changes in the hydrogen ion concentration can disrupt cell membrane stability, alter protein structures, and change enzyme activities. The normal pH of arterial blood is 7.4, venous blood and interstitial fluid is 7.35, and intracellular fluid averages 7.0.
When the pH of arterial blood rises above 7.45, it results in a condition called alkalosis. Conversely, a drop below 7.35 leads to...
When the pH of arterial blood rises above 7.45, it results in a condition called alkalosis. Conversely, a drop below 7.35 leads to...
2.6K