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

Beneficial value of [18F]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

Nicole E Billingy #  1 , Cornelia A Verberkt #  2 , Idris Bahce  3 , Marloes J Hassing  2 , Joran Schoorlemmer  2 , Merve Sarioglu  2 , Suresh Senan  4 , Erik H J G Aarntzen  5 , Emile F I Comans  6 , Wietske Kievit  2 , Steven Teerenstra  2 , Colin Jacobs  5 , Astrid Keijser  7 , Michel M van den Heuvel  8 , Annemarie Becker-Commissaris  3 , Iris Walraven  2 ; The NVALT31-PET Consortium
Collaborators, Affiliations

Beneficial value of [18F]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

Nicole E Billingy et al. BMJ Open. .

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'-[18F]fluoroglucose positron emission tomography/CT ([18F]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 [18F]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 ([18F]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.

Keywords: Diagnostic Imaging; ONCOLOGY; Respiratory tract tumours.

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Conflict of interest statement

Competing interests: SS: Varian Medical Systems – Departmental research support. AstraZeneca – Institutional research support, speaker’s honoraria, trial steering committee (payments to institution). MSD – Speaker’s honoraria, consultancy (payments to institution). Lilly – Steering committee (payments to institution). MvdH: MvdH has received institutional grant funding and payments for educational activities/webinars. MvdH is a member of advisory boards for AbbVie, Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Janssen, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi and Takeda. MvdH is chair of the NVALT Studies Foundation and chair of the oncology section of NVALT. MvdH serves as local principal investigator for clinical trials sponsored by AstraZeneca, BMS, GSK, Novartis, Merck, Roche, Takeda, Mirati, AbbVie, MSD, Merck, Amgen, Boehringer Ingelheim and Pfizer. All payments were made to the institution. All other authors have no competing interests to declare.

Figures

Figure 1
Figure 1. Flow chart of the trial design. [18F]FDG PET/CT, 2′-deoxy-2′-[18F]fluoroglucose positron emission tomography/CT; FU, follow-up; HRQOL, health-related quality of life; NSCLC, non-small cell lung cancer.
See this image and copyright information in PMC

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