Using PET/CT scans to improve follow-up care for stage III 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
This study is testing if using special PET/CT scans can help stage III lung cancer patients live longer and have better follow-up care compared to regular CT scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 690 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 27 sites (Hilversum, Utrecht and 26 other locations) |
| Trial ID | NCT06082492 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computerized Tomography (18F FDG PET/CT) scans in improving the 3-year overall survival of patients with stage III non-small cell lung cancer (NSCLC) during follow-up care. Participants will be divided into two groups: one receiving standard follow-up care with conventional CT scans and the other receiving additional 18F FDG PET/CT scans at specified intervals. The study will also assess the cost-effectiveness of this imaging approach and gather quality of life data through questionnaires and optional interviews. The goal is to determine if earlier detection of recurrences can lead to better treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with cytologically or histologically confirmed stage III NSCLC who are starting follow-up care after curative intent treatment.
Not a fit: Patients with stage III NSCLC who are not starting follow-up care or those with a performance status worse than ECOG 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with stage III NSCLC.
How similar studies have performed: Previous studies have shown promising results with advanced imaging techniques in cancer follow-up, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hilversum, Utrecht and 26 other locations
- Tergooi MC — Hilversum, Utrecht, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Antoni van Leeuwenhoek/Nederlands Kanker Instituut — Amsterdam, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Recruiting)
- Gelre Ziekenhuizen — Apeldoorn & Zutphen, Netherlands (Recruiting)
- Amphia Ziekenhuis — Breda, Netherlands (Recruiting)
- Deventer Ziekenhuis — Deventer, Netherlands (Recruiting)
- Ziekenhuis Gelderse Vallei — Ede, Netherlands (Recruiting)
- Máxima Medisch Centrum — Eindhoven & Veldhoven, Netherlands (Recruiting)
- Treant — Emmen, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- Groene Hart Ziekenhuis — Gouda, Netherlands (Recruiting)
- Martini Ziekenhuis — Groningen, Netherlands (Recruiting)
- Tjongerschans ziekenhuis — Heerenveen, Netherlands (Recruiting)
- Dijklander Ziekenhuis — Hoorn, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Netherlands (Recruiting)
- Bravis Ziekenhuis — Roosendaal, Netherlands (Recruiting)
- Maasstad ZIekenhuis — Rotterdam, Netherlands (Recruiting)
- Franciscus Gasthuis & Vlietland — Schiedam, Netherlands (Recruiting)
- Haaglanden Medisch Centrum — The Hague, Netherlands (Recruiting)
- HagaZiekenhuis — The Hague, Netherlands (Recruiting)
- Elisabeth-TweeSteden Ziekenhuis — Tilburg, Netherlands (Recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
- St. Antonius Ziekenhuis — Utrecht & Nieuwegein, Netherlands (Recruiting)
- Streekziekenhuis Koningin Beatrix — Winterswijk, Netherlands (Recruiting)
Study contacts
- Principal investigator: Iris Walraven, PhD. — Radboud University Medical Center
- Study coordinator: NVALT31-PET study team
- Email: NVALT31PET@radboudumc.nl
- Phone: +31611469084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.