Clinical trial · Interventional
The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients
The Beneficial Value of 18F FDG PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients: the NVALT31-PET Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F-Fluorodeoxyglucose Positron Emission Tomography/ Computerized Tomography (18F FDG PET/CT) versus follow-up with conventional CT surveillance. Participants will receive usual care until 3 years of follow-up (control group) with additional whole-body 18F FDG PET/CT scans during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up in the intervention group. Other tasks include: * filling in quality of life (QOL) questionnaires at every time point; * participating in an interview evaluating the addition of the 18F FDG PET/CT scans (optional); * collecting blood at the follow-up time points for our secondary endpoint (optional). Researchers will compare the usual care control group with the intervention group to see if the additional 18F FDG PET/CT scans are (cost-)effective.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
| CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The intervention group (n = 345) consists of usual care until 3 years of follow-up (see comparator) with additional whole-body 18F FDG PET/CT scans (from the skull to, at least, the midfemoral region) during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up. After the 36-month follow-up period, patients will receive follow-up usual care (i.e. CT-scans). The scanning protocol of Boellaard et al (2015) is the basis of all center-specific protocols and therefore will be followed approximately (PET low dose CT 60 minutes post injection with scan trajectory from skull to (at least the) thighs followed by a CT scan).
- interventionNames
- Diagnostic Test: 18F FDG PET/CT
- Diagnostic Test: CT scan
- type
- ACTIVE_COMPARATOR
- label
- Control group (care as usual)
- description
- The control group (n = 345) consists of regular follow-up visits with physical check-ups and CT-scans at least every 6 months for the first 2 years and then at least yearly CT-scans until 3 years of follow-up. In case of suspected recurrence/metastasis or inconclusive results of a CT-scan (eg, after radiotherapy), 18F FDG PET/CT should be considered. The standard protocol for a diagnostic CT of the thoracic region during IV contrast administration according to the lung tumor protocol will be followed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligible for this study are patients with stage III NSCLC (8th edition TNM Classification) who (are about to) start(ed) follow-up care (which may include adjuvant treatment) at a participating hospital. Patients may already be included during their curative intent treatment. Patients enter a screening period that runs until their randomization. Inclusion Criteria: To be eligible to participate in this study, a subject must meet all of the following criteria at the timing of randomization: * Cytological or histologically proven stage III non-small cell lung cancer before start of curative intent treatment * Treated with curative intent and started follow-up care * All adjuvant treatments are permitted as co-intervention during follow-up care * Age 18 years or older * ECOG Performance Status classification 0-2 at moment of inclusion * Written and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care) Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Life expectancy shorter than 6 months at the end of curative intent treatment * Evidence of recurrence after end of curative intent treatment and before randomization (4 months follow-up) * Any condition that, in the opinion of the investigator, would interfere with evaluation of the intervention or interpretation of HRQOL or other study results.
References
Publications (1)
- DERIVEDBillingy NE, Verberkt CA, Bahce I, Hassing MJ, Schoorlemmer J, Sarioglu M, Senan S, Aarntzen EHJG, Comans EFI, Kievit W, Teerenstra S, Jacobs C, Keijser A, Heuvel MMVD, Becker-Commissaris A, Walraven I; The NVALT31-PET Consortium. 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. BMJ Open. 2025 Jul 25;15(7):e103745. doi: 10.1136/bmjopen-2025-103745. PMID 40713037