Radionuclide imaging is divided into positron emission tomography and single photon emission tomography and is widely used in clinical practice for diagnosis and treatment, as well as in clinical research for the development and evaluation of new therapies. Although it is a visually intuitive form of three‐dimensional functional imaging, this modality requires the injection of radiopharmaceuticals labeled with positron‐ or gamma‐emitting isotopes into patients to assess and quantify anabolism, gene expression, and other processes. For this reason, radiopharmaceuticals must undergo rigorous quality control (QC) to ensure product purity, efficacy, and safety. Traditional QC of pharmaceuticals is manual, requiring specially trained personnel, a range of expensive analytical and chemical equipment and laboratory space, the consumption of many samples, and usually a long time. Compared with ordinary pharmaceuticals, radiopharmaceuticals have the following unique characteristics: radioactivity, short lifetime, low synthesis yield, and high cost. Therefore, analytical methods and instrumentation must be exclusively developed for the QC of radiopharmaceuticals to avoid large losses owing to radioactive decay or handling. Microfluidics integrates microchannels or microchambers into several square centimeters of a microscale chip through micro–nanofabrication, allowing a precise manipulation of the fluid in microtubules, where various traditional physical, chemical, or biological experiments occur. Microfluidics is gaining attention in the field of analytical testing owing to significantly reduced consumption of samples and reagents, reduced analysis time, increased detection sensitivity, increased multiplexing, and reduced instrument size. Features such as micro size, micro volume, high sensitivity, and on‐line testing have led to increasing interest in microfluidics. This review covers the development of integrated microfluidic QC devices that can automatically process, test, analyze, and calculate completed test metrics online.
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Vascular thrombus is a common complication in cancer patients and can be classified as benign or neoplastic based on tumor cell presence. Conventional imaging modalities provide anatomical information but exhibit limited specificity in distinguishing neoplastic from benign thrombi, prompting the evaluation of 2‐deoxy‐2‐[18F]fluoro‐D‐glucose positron emission tomography/computed tomography ([18F]FDG PET/CT), which leverages metabolic differences for improved differentiation. In this study, the efficacy of [18F]FDG PET/CT for differentiating neoplastic thrombus from benign thrombus was evaluated in patients with malignant tumors.
Sixty‐five patients with histologically or clinically confirmed neoplastic or benign thrombus who underwent [18F]FDG PET/CT were retrospectively enrolled. Both visual and semi‐quantitative analyses of the PET/CT scans were conducted. The difference in maximum standardized uptake value (SUVmax) between neoplastic and benign thrombus was assessed using a t‐test. Furthermore, receiver operating characteristics (ROC) analysis was performed to determine the optimal SUVmax threshold for differentiating neoplastic from benign thrombus.
Within the cohort, 55 patients were diagnosed with neoplastic thrombus and 10 patients with benign thrombus. In the visual analysis, the sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of [18F]FDG PET/CT for diagnosing neoplastic thrombus were 96.4%, 90.0%, 98.1%, 81.8%, and 95.4%, respectively. In the semi‐quantitative analysis, the sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy for diagnosing neoplastic thrombus were 96.4%, 100%, 100%, 83.3%, and 96.9%, respectively. The normalized SUVmax of neoplastic thrombus was significantly higher than that of benign thrombus (10.11 ± 5.32 vs. 2.21 ± 0.51, p < 0.001). The area under the ROC curves for visual assessment and semi‐quantitative analysis were 0.932 and 0.993, respectively. There was no statistically significant difference observed between these two assessment methods (p = 0.317).
[18F]FDG PET/CT is capable of differentiating neoplastic thrombus from benign thrombus. Both visual and semi‐quantitative analyses demonstrated high diagnostic sensitivity, specificity, and accuracy.
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