宫颈癌2[18F]-FDG-PET/CT和-PET/MRI初步分期及MRI放疗反应评价:一项前瞻性临床试验的中期分析

Maja Aasa, David Lindquist, Ulrika Ottander, Sara N Strandberg
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引用次数: 0

摘要

背景:在子宫癌(UCC)中,肿瘤分期是根据2018年国际妇产科学联合会(FIGO)系统进行的,其中纳入了影像学,或更通用的肿瘤淋巴结转移(TNM)分类。随着诊断成像技术的发展,不同的成像方法有助于分期确定的持续前瞻性评价是有必要的。本中期研究的目的是(1)评估2-氟-18-氟脱氧葡萄糖(2[18F]-FDG)-正电子发射断层扫描与计算机断层扫描(PET/CT)和磁共振成像(PET/MRI)的放射FIGO (rFIGO)和T分期(rT)的性能,与treatment-naïve UCC中基于临床检查和常规影像学的临床FIGO (cFIGO)和T (CT)分期进行比较;(2)确定放射治疗后早期治疗反应可能的MRI生物标志物。方法:前瞻性PRODIGYN(医学影像学在妇科肿瘤分期和治疗计划中的预后和诊断附加值)研究中连续10例新诊断的UCC患者(伦理批准号2022-04207-01;包括NCT05855941)。研究参与者接受了2[18F]FDG-PET/CT和-PET/MRI检查,并在放疗后一周进行了额外的MRI检查。使用Cohen’s kappa分析rFIGO和cFIGO之间的一致性。采用Wilcoxon秩检验评价2[18F]FDG-PET/CT与-PET/MRI rFIGO的差异,并采用描述性统计证明rFIGO对转移评估的附加值。结果:在2/10的患者中,与cFIGO相比,rFIGO获得了更高的分期,其中转移的存在导致了抢先期。3/10 rFIGO低于cFIGO, 5/10 rFIGO与cFIGO相似。rFIGO与cFIGO的一致程度较差(κ = 0.091, p 0.05)。2[18F]FDG-PET/CT和-PET/MRI对rFIGO的评估无显著差异(p = 0.18),或rT分期评估(p = 0.32)。MRI衍生肿瘤体积和表观扩散系数(ADC)在放疗后一周的MRI上受影响最大。结论:我们的研究结果表明,与临床检查和常规放射学相比,2[18F]FDG-PET/CT和-PET/MRI的rFIGO分期对treatment-naïve UCC的转移评估具有附加价值。在MRI早期治疗反应评估中,ADC和肿瘤体积可能是未来预后分析中感兴趣的预测参数。试验注册:临床试验,NCT05855941。2023年5月2日注册,https://clinicaltrials.gov/study/NCT05855941?term=NCT05855941&rank=1。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Primary staging with 2[18F]-FDG-PET/CT and -PET/MRI and radiotherapy response evaluation with MRI in uterine cervical cancer: an interim analysis of a prospective clinical trial.

Background: In uterine cervical cancer (UCC), tumour staging is performed according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) system, where imaging is incorporated, or the more generic Tumour Node Metastasis (TNM) classification. With the technical development in diagnostic imaging, continuous prospective evaluation of the different imaging methods contributing to stage determination is warranted. The aims of this interim study were to (1) evaluate the performance of radiological FIGO (rFIGO) and T staging (rT) with 2-fluorine-18-fluoro-deoxy-glucose (2[18F]-FDG)-positron emission tomography with computed tomography (PET/CT) and with magnetic resonance imaging (PET/MRI), compared to clinical FIGO (cFIGO) and T (cT) staging based on clinical examination and conventional imaging, in treatment-naïve UCC, and to (2) identify possible MRI biomarkers for early treatment response after radiotherapy.

Methods: Ten consecutive patients with newly diagnosed UCC from the prospective PRODIGYN (Prognostic and Diagnostic Added Value of Medical Imaging in Staging and Treatment Planning of Gynecological Cancer) study (ethical approval number 2022-04207-01; NCT05855941) were included. Study participants underwent 2[18F]FDG-PET/CT and -PET/MRI, and an additional MRI one week after radiotherapy. Agreement between rFIGO and cFIGO was analysed using Cohen's kappa. Differences in rFIGO between 2[18F]FDG-PET/CT and -PET/MRI were evaluated with Wilcoxon signed ranks test, and added value of rFIGO for metastasis assessment was demonstrated with descriptive statistics.

Results: In 2/10 patients, a higher stage was obtained with rFIGO compared to cFIGO, where presence of metastases led to upstaging. In 3/10, rFIGO was lower than cFIGO, and in 5/10 rFIGO and cFIGO were similar. Degree of agreement between rFIGO and cFIGO was poor, (κ = 0.091, p < 0.005) with 2[18F]FDG-PET/CT and (κ = - 0.010, p > 0.05) with FDG/PET/MRI). There was no significant difference between 2[18F]FDG-PET/CT and -PET/MRI for rFIGO (p = 0.18), or rT stage assessment (p = 0.32). MRI-derived tumour volume and apparent diffusion coefficient (ADC) were most affected on MRI one week after radiotherapy.

Conclusions: Our results indicate that there is an added value of rFIGO staging with 2[18F]FDG-PET/CT and -PET/MRI compared to clinical examination and conventional radiology, for metastasis assessment in treatment-naïve UCC. In early treatment response evaluation with MRI, ADC and tumour volume may be predictive parameters of interest in future prognostic analyses.

Trial registration: Clinical Trials, NCT05855941. Registered 02 May 2023, https://clinicaltrials.gov/study/NCT05855941?term=NCT05855941&rank=1 .

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