TY - JOUR
T1 - Beneficial value of [ 18 F]FDG PET/CT in the follow-up of patients with stage III non-small cell lung cancer (NVALT31-PET study)
T2 - Study protocol of a multicentre randomised controlled trial
AU - Billingy, Nicole E.
AU - Verberkt, Cornelia A.
AU - Bahce, Idris
AU - Hassing, Marloes J.
AU - Schoorlemmer, Joran
AU - Sarioglu, Merve
AU - Senan, Suresh
AU - Aarntzen, Erik H. J. G.
AU - Comans, Emile F. I.
AU - Kievit, Wietske
AU - Teerenstra, Steven
AU - Jacobs, Colin
AU - Keijser, Astrid
AU - Heuvel, Michel M. Van Den
AU - Becker-Commissaris, Annemarie
AU - Walraven, Iris
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
PY - 2025/7/25
Y1 - 2025/7/25
N2 - 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′-[ 18 F]fluoroglucose positron emission tomography/CT ([ 18 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 [ 18 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 ([ 18 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.
AB - 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′-[ 18 F]fluoroglucose positron emission tomography/CT ([ 18 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 [ 18 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 ([ 18 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.
KW - Diagnostic Imaging
KW - ONCOLOGY
KW - Respiratory tract tumours
UR - https://www.scopus.com/pages/publications/105011772662
U2 - 10.1136/bmjopen-2025-103745
DO - 10.1136/bmjopen-2025-103745
M3 - Article
C2 - 40713037
SN - 2044-6055
VL - 15
JO - BMJ open
JF - BMJ open
IS - 7
M1 - e103745
ER -
