The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients
NVALT31-PET
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
2 other identifiers
interventional
690
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
March 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
February 5, 2025
December 1, 2024
5 years
September 27, 2023
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival (OS) will be defined as time from end of curative intent treatment until death or loss to follow-up or end of study defined as 3 years after end of curative treatment.
3 years after end of curative intent treatment
Secondary Outcomes (8)
Number of detected symptomatic and asymptomatic recurrences
Up to 3 years after end of curative intent treatment
Event-free survival (EFS)
3 years after end of curative intent treatment
Quality-adjusted life-years ((QALY's) for the cost-effectiveness analysis (CEA))
Up to 3 years after end of curative intent treatment
Hospital and medical resource use (for the CEA)
Up to 3 years after end of curative intent treatment
Productivity losses (for the CEA)
Up to 3 years after end of curative intent treatment
- +3 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALThe 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).
Control group (care as usual)
ACTIVE COMPARATORThe 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
Interventions
Additional 18F FDG PET/CT scans during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.
CT of the thoracic region during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Amsterdam UMC, location VUmccollaborator
- Streekziekenhuis Koningin Beatrixcollaborator
- Canisius-Wilhelmina Hospitalcollaborator
- Diakonessenhuis, Utrechtcollaborator
- Dijklander Ziekenhuiscollaborator
- Deventer Ziekenhuiscollaborator
- Elisabeth-TweeSteden Ziekenhuiscollaborator
- Gelre Hospitalscollaborator
- Groene Hart Ziekenhuiscollaborator
- HagaZiekenhuiscollaborator
- Martini Hospital Groningencollaborator
- Medisch Spectrum Twentecollaborator
- St. Antonius Hospitalcollaborator
- Franciscus &Vlietlandcollaborator
- Tjongerschanscollaborator
- Maasstadziekenhuiscollaborator
- Gelderse Vallei Hospitalcollaborator
- Bravis Hospitalcollaborator
- Tergooi Hospitalcollaborator
- Treant Zorggroepcollaborator
- Amphia Hospitalcollaborator
- UMC Utrechtcollaborator
- OLVGcollaborator
- Haaglanden Medical Centrecollaborator
- Antoni van Leeuwenhoek Hospitalcollaborator
Study Sites (27)
Tergooi MC
Hilversum, Utrecht, 1212 VG, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Antoni van Leeuwenhoek/Nederlands Kanker Instituut
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn & Zutphen, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Máxima Medisch Centrum
Eindhoven & Veldhoven, Netherlands
Treant
Emmen, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Tjongerschans ziekenhuis
Heerenveen, Netherlands
Dijklander Ziekenhuis
Hoorn, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Radboudumc
Nijmegen, Netherlands
Bravis Ziekenhuis
Roosendaal, Netherlands
Maasstad ZIekenhuis
Rotterdam, Netherlands
Franciscus Gasthuis & Vlietland
Schiedam, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
Diakonessenhuis
Utrecht, Netherlands
UMC Utrecht
Utrecht, Netherlands
St. Antonius Ziekenhuis
Utrecht & Nieuwegein, Netherlands
Streekziekenhuis Koningin Beatrix
Winterswijk, Netherlands
Related Publications (1)
Billingy 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: 40713037DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iris Walraven, PhD.
Radboud University Medical Center
- PRINCIPAL INVESTIGATOR
Annemarie Becker-Commissaris, PhD./MD.
Amsterdam UMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 13, 2023
Study Start
March 19, 2024
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
February 5, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data will become available after NVALT31- PET study investigators have performed the analyses needed for this study.
- Access Criteria
- All data will be available on request. Access to the data will be guarded by the CMO Radboudumc and the NVALT31-PET data access committee (DAC) and may be requested by other researchers from Radboudumc and Amsterdam UMC. Also, the data can be used in collaboration with other groups (abroad).
Final (definitive) versions of data used for analysis will be made findable and shared for reuse and/or verification. Documentation/codebooks necessary for understanding the data will be made findable and shared for reuse and/or verification. Left-over blood samples will be made findable and can be accessed to share for reuse and/or verification. Metadata will be published in DANS. Metadata of the blood samples and scans will also be published in BBMRI. Crossreferences between DANS and BBMRI will be included. A DOI will be assigned to the whole dataset published in DANS Data Station Life, Health and Medical Sciences.