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Abstract：
BACKGROUND: Tuberculosis (TB) is one of the top ten causes of death worldwide, with approximately 10 million cases annually. Focus has been on pulmonary TB, while extrapulmonary TB (EPTB) has received little attention. Diagnosis of EPTB remains challenging due to the invasive procedures required for sample collection. Spinal TB (STB) accounts for 10% of EPTB and often leads to lifelong debilitating disease due to devastating spinal deformation and compression of neural structures. Little is known about the extent of disease, although both isolated STB and a disseminated form of STB have been described. In our Spinal TB X cohort study, we aim to describe the clinical phenotype of STB using whole-body 18FDG-PET/CT, identify a specific gene expression profile for different stages of dissemination and compare findings to previously described gene expression signatures for latent and active pulmonary TB.
METHODS: A single-centre, prospective cohort study will be established to describe the distributional pattern of STB detected by whole-body 18FDG-PET/CT and gene expression profile of patients with suspected STB on magnetic resonance imaging (MRI) at point of diagnosis, six months, and 12 months. Blood biobanking will be performed at these time points. Specimens for microbiology will be obtained from sputum/urine, from easily accessible sites of disease (e.g., lymph nodes, abscess) identified in the first 18FDG-PET/CT, from CT-guided biopsy and/or surgery. Clinical parameters and functional scores will be collected at every physical visit. Data will be entered into RedCap® database; data cleaning, validation and analysis will be performed by the study team. The University of Cape Town Ethics Committee approved the protocol (243/2022).
CONCLUSIONS: The Spinal TB X cohort study is the first prospective cohort study using whole-body 18FDG-PET/CT scans in patients with microbiologically confirmed spinal tuberculosis. Dual imaging techniques of the spine using 18FDG-PET/CT and magnetic resonance imaging as well as tissue diagnosis (microbiology and histopathology) will allow us to develop a virtual biopsy model. If successful, a distinct gene-expression profile will aid in blood-based diagnosis (point of care testing) as well as treatment monitoring and would lead to earlier diagnosis of this devastating disease.
BACKGROUND: The study has been registered on ClinicalTrials.gov (NCT05610098).
METHODS: A single-centre, prospective cohort study will be established to describe the distributional pattern of STB detected by whole-body 18FDG-PET/CT and gene expression profile of patients with suspected STB on magnetic resonance imaging (MRI) at point of diagnosis, six months, and 12 months. Blood biobanking will be performed at these time points. Specimens for microbiology will be obtained from sputum/urine, from easily accessible sites of disease (e.g., lymph nodes, abscess) identified in the first 18FDG-PET/CT, from CT-guided biopsy and/or surgery. Clinical parameters and functional scores will be collected at every physical visit. Data will be entered into RedCap® database; data cleaning, validation and analysis will be performed by the study team. The University of Cape Town Ethics Committee approved the protocol (243/2022).
CONCLUSIONS: The Spinal TB X cohort study is the first prospective cohort study using whole-body 18FDG-PET/CT scans in patients with microbiologically confirmed spinal tuberculosis. Dual imaging techniques of the spine using 18FDG-PET/CT and magnetic resonance imaging as well as tissue diagnosis (microbiology and histopathology) will allow us to develop a virtual biopsy model. If successful, a distinct gene-expression profile will aid in blood-based diagnosis (point of care testing) as well as treatment monitoring and would lead to earlier diagnosis of this devastating disease.
BACKGROUND: The study has been registered on ClinicalTrials.gov (NCT05610098).
摘要：
背景：结核病（TB）是全球十大死亡原因之一，每年大约有1000万例。重点是肺结核，而肺外结核（EPTB）很少受到关注。由于样品收集所需的侵入性程序，EPTB的诊断仍然具有挑战性。脊柱TB(STB)占EPTB的10%,并且由于毁灭性的脊柱变形和神经结构的压迫,常常导致终生衰弱的疾病。对疾病的程度知之甚少，尽管已经描述了分离的STB和散布形式的STB。在我们的脊髓结核X队列研究中，我们的目的是使用全身18FDG-PET/CT描述STB的临床表型，鉴定不同播散阶段的特定基因表达谱，并将发现与先前描述的潜伏性和活动性肺结核的基因表达特征进行比较。
方法：单中心，将建立前瞻性队列研究，以描述通过全身18FDG-PET/CT检测到的STB的分布模式和在诊断点的磁共振成像（MRI）上疑似STB患者的基因表达谱，六个月,和12个月。将在这些时间点进行血液生物分析。微生物学标本将从痰/尿液中获得，从容易到达的疾病部位(例如，淋巴结,脓肿）在第一次18FDG-PET/CT中确定，CT引导活检和/或手术。临床参数和功能评分将在每次体检时收集。数据将输入到RedCap®数据库；数据清理，验证和分析将由研究小组进行.开普敦大学伦理委员会批准了该协议（243/2022）。
结论：脊柱结核X队列研究是第一个在微生物学证实的脊柱结核患者中使用全身18FDG-PET/CT扫描的前瞻性队列研究。使用18FDG-PET/CT和磁共振成像以及组织诊断（微生物学和组织病理学）的脊柱双重成像技术将使我们能够开发虚拟活检模型。如果成功,独特的基因表达谱将有助于基于血液的诊断(护理点检测)以及治疗监测,并将导致对这种破坏性疾病的早期诊断.
背景：该研究已在ClinicalTrials.gov（NCT05610098）上注册。
方法：单中心，将建立前瞻性队列研究，以描述通过全身18FDG-PET/CT检测到的STB的分布模式和在诊断点的磁共振成像（MRI）上疑似STB患者的基因表达谱，六个月,和12个月。将在这些时间点进行血液生物分析。微生物学标本将从痰/尿液中获得，从容易到达的疾病部位(例如，淋巴结,脓肿）在第一次18FDG-PET/CT中确定，CT引导活检和/或手术。临床参数和功能评分将在每次体检时收集。数据将输入到RedCap®数据库；数据清理，验证和分析将由研究小组进行.开普敦大学伦理委员会批准了该协议（243/2022）。
结论：脊柱结核X队列研究是第一个在微生物学证实的脊柱结核患者中使用全身18FDG-PET/CT扫描的前瞻性队列研究。使用18FDG-PET/CT和磁共振成像以及组织诊断（微生物学和组织病理学）的脊柱双重成像技术将使我们能够开发虚拟活检模型。如果成功,独特的基因表达谱将有助于基于血液的诊断(护理点检测)以及治疗监测,并将导致对这种破坏性疾病的早期诊断.
背景：该研究已在ClinicalTrials.gov（NCT05610098）上注册。
