Clinical trial · Interventional
Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy
Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial
- 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 purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients. The investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body Positron Emission Tomography combined with Computer Tomography (PET/CT) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole body 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A, PET/CT
- description
- 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) replacing computed tomography (CT) at months 6, 12, 18 and 24, otherwise as B with CT scan months 9, 15 and 21. Quality of life assessment and liquid biopsy every 3 months for later analysis.
- interventionNames
- Diagnostic Test: Whole body 18F-FDG PET/CT
- type
- NO_INTERVENTION
- label
- Control arm B
- description
- CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis.
Primary outcomes (1)
- measure
- Number of relapses treatable with curative intent
- timeFrame
- Until first detected relapse or 2 years after enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with non-small cell lung cancer (NSCLC), proven by cytology or histology * Patient in clinical stages I-III * Age≥ 18 years * Performance status ≤ 2 at the time of referral to therapy * Patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation). * Patient has given his/her written informed consent before any specific procedure from protocol Exclusion Criteria: * Patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on CT. * Persons deprived of liberty or under guardianship or curators * Dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial * Pregnant or breastfeeding women * Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in SUPE-R. Participation in protocols related only to initial treatment will not preclude participation in SUPE-R. Cases of doubt will be settled by the steering committee.
References
Publications (2)
- DERIVEDGuldbrandsen KF, Bloch M, Skougaard K, Albrecht-Beste E, Nellemann HM, Krakauer M, Gortz PM, Gruner JM, Fledelius J, Nielsen AL, Holdgaard PC, Nielsen SS, Hjorthaug K, Ahlborn LB, Jakobsen E, Hojsgaard A, Petersen RH, Moller LB, Dahl M, Sorensen BS, Frank MS, Ehlers JH, Saghir Z, Pohl M, Borissova S, Land LH, Kristiansen C, McCulloch T, Mortensen LS, Christophersen MS, Hilberg O, Rasmussen TL, Schwaner SHS, Laursen CB, Bodtger U, Lonsdale MN, Meyer CN, Gerke O, Mortensen J, Rasmussen TR, Fischer BM; SUPE_R Study Group. Diagnostic Accuracy of [18F]FDG PET/CT versus CT for NSCLC Surveillance: Secondary Analysis of a Randomized Clinical Trial. Clin Lung Cancer. 2026 Apr;27(3):180-189.e1. doi: 10.1016/j.cllc.2025.11.011. Epub 2025 Nov 19. PMID 41387040
- DERIVEDGuldbrandsen KF, Bloch M, Skougaard K, Ahlborn LB, Jakobsen E, Hojsgaard A, Petersen RH, Moller LB, Dahl M, Sorensen BS, Frank MS, Ehlers JH, Krakauer M, Gortz PM, Albrecht-Beste E, Gruner JM, Saghir Z, Fledelius J, Nielsen AL, Holdgaard PC, Nielsen SS, Pohl M, Borissova S, Land LH, Kristiansen C, McCulloch T, Mortensen LS, Nellemann HM, Christophersen MS, Hilberg O, Rasmussen TL, Schwaner SHS, Laursen CB, Bodtger U, Sopina L, Lonsdale MN, Meyer CN, Gerke O, Mortensen J, Rasmussen TR, Fischer BM; SUPE_R Study Group. Surveillance With Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography of Patients With Stage I-to-III Lung Cancer After Completion of Curative treatment (SUPE_R): A Randomized Controlled Trial. J Thorac Oncol. 2025 Aug;20(8):1086-1097. doi: 10.1016/j.jtho.2025.04.003. Epub 2025 Apr 19. PMID 40258572