Nuclear Medicine Department, IRCCS - Humanitas Research Hospital, Rozzano, Italy
Pediatric Onco-hematologic Unit, University Hospital Arcispedale Sant'Anna of Ferrara, Ferrara, Italy.
BMJ Open. 2021 Mar 29;11(3):e041252. doi: 10.1136/bmjopen-2020-041252.
Assessment of response to therapy in paediatric patients with Hodgkin lymphoma (HL) by 18F-fluorodeoxyglucose positron emission tomography/CT has become a powerful tool for the discrimination of responders from non-responders. The addition of volumetric and texture analyses can be regarded as a valuable help for disease prognostication and biological characterisation. Based on these premises, the Hodgkin Lymphoma Study Group of the Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) has designed a prospective evaluation of volumetric and texture analysis in the Italian cohort of patients enrolled in the EuroNet-PHL-C2.
The primary objective is to compare volumetric assessment in patiens with HL at baseline and during the course of therapy with standard visual and semiquantitative analyses. The secondary objective is to identify the impact of volumetric and texture analysis on bulky masses. The tertiary objective is to determine the additional value of multiparametric assessment in patients having a partial response on morphological imaging.The overall cohort of the study is expected to be round 400-500 patients, with approximately half presenting with bulky masses. All PET scans of the Italian cohort will be analysed for volumetric assessment, comprising metabolic tumour volume and total lesion glycolysis at baseline and during the course of therapy. A dedicated software will delineate semiautomatically contours using different threshold methods, and the impact of each segmentation techniques will be evaluated. Bulky will be defined on contiguous lymph node masses ≥200 mL on CT/MRI. All bulky masses will be outlined and analysed by the same software to provide textural features. Morphological assessment will be based on RECIL 2017 for response definition.
The current study has been ethically approved (AIFA/SC/P/27087 approved 09/03/2018; EudraCT 2012-004053-88, EM-04). The results of the different analyses performed during and after study completion the will be actively disseminated through peer-reviewed journals, conference presentations, social media, print media and internet.
18F-氟代脱氧葡萄糖正电子发射断层扫描/计算机断层扫描（18F-FDG PET/CT）评估儿童霍奇金淋巴瘤（HL）患者的治疗反应已成为区分应答者和无应答者的有力工具。加入容积和纹理分析可以被视为疾病预后和生物学特征的有价值的帮助。基于这些前提，意大利儿科血液学和肿瘤学协会（AIEOP）霍奇金淋巴瘤研究组设计了一项前瞻性评估，即在参加欧洲网络-PHL-C2 的意大利患者队列中评估容积和纹理分析。
主要目的是比较基线和治疗过程中 HL 患者的容积评估与标准视觉和半定量分析。次要目的是确定容积和纹理分析对大肿块的影响。第三个目标是确定在形态学成像上有部分反应的患者中，多参数评估的附加价值。研究的总队列预计约为 400-500 例患者，其中大约一半有大肿块。意大利队列的所有 PET 扫描都将进行容积评估分析，包括基线和治疗过程中的代谢肿瘤体积和总病变糖酵解。专用软件将使用不同的阈值方法半自动勾勒轮廓，并评估每种分割技术的影响。大肿块定义为 CT/MRI 上连续的淋巴结肿块≥200 mL。将使用相同的软件勾勒和分析所有大肿块，以提供纹理特征。形态学评估将基于 RECIL 2017 定义反应。
本研究已获得伦理批准（AIFA/SC/P/27087 于 2018 年 3 月 9 日批准；EudraCT 2012-004053-88，EM-04）。在研究完成期间和之后进行的不同分析的结果将通过同行评议期刊、会议演讲、社交媒体、印刷媒体和互联网积极传播。
