[F]FDG PET/CT在Ⅲ期非小细胞肺癌患者随访中的有益价值（NVALT31-PET研究）：一项多中心随机对照试验的研究方案

Beneficial value of [F]FDG PET/CT in the follow-up of patients with stage III non-small cell lung cancer (NVALT31-PET study): study protocol of a multicentre randomised controlled trial.

作者信息

Billingy Nicole E, Verberkt Cornelia A, Bahce Idris, Hassing Marloes J, Schoorlemmer Joran, Sarioglu Merve, Senan Suresh, Aarntzen Erik H J G, Comans Emile F I, Kievit Wietske, Teerenstra Steven, Jacobs Colin, Keijser Astrid, Heuvel Michel M van den, Becker-Commissaris Annemarie, Walraven Iris

机构信息

IQ Health Science Department, Radboud University Medical Center, Nijmegen, The Netherlands

IQ Health Science Department, Radboud University Medical Center, Nijmegen, The Netherlands.

出版信息

BMJ Open. 2025 Jul 25;15(7):e103745. doi: 10.1136/bmjopen-2025-103745.

DOI:10.1136/bmjopen-2025-103745

PMID:40713037

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12306341/

Abstract

INTRODUCTION

Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50-78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[F]fluoroglucose positron emission tomography/CT ([F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

METHODS AND ANALYSIS

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

ETHICS AND DISSEMINATION

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

TRIAL REGISTRATION NUMBER

NCT06082492.

摘要

引言

III期非小细胞肺癌（NSCLC）患者在随访期间发生治疗后复发的风险很高（50%-78%）。由于现在有了更有效的治疗方法，特别是对于寡转移疾病患者，更早地检测到复发可能会延长生存期和与健康相关的生活质量（HRQOL）。在随访期间使用2'-脱氧-2'-[F]氟葡萄糖正电子发射断层扫描/计算机断层扫描（[F]FDG PET/CT），可能会更早地检测到复发。因此，本研究的主要目的是比较III期NSCLC患者在随访监测期间使用[F]FDG PET/CT与使用传统CT（常规护理）进行随访的3年总生存率。次要目标涉及复发的数量、位置和时间，以及PET/CT扫描的HRQOL、成本效益和患者体验。

方法与分析

在这项多中心随机对照临床试验中，690例完成根治性治疗并开始随访护理（可能包括辅助治疗）的III期NSCLC患者（第8版国际肺癌研究协会（IASLC）肿瘤、淋巴结、转移（TNM）分类）将按1:1随机分为干预组（[F]FDG PET/CT）或对照组（CT）。患者将在第6、12、18、24和36个月就诊时接受随访扫描。数据将使用经过验证的问卷、电子病例报告表以及从电子健康记录中提取的数据进行收集。此外，还将采集血样并进行访谈。