Carcinoma, Non-Small-Cell LungSUPE_RNCT03740126
Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy
A study testing Whole body 18F-FDG PET/CT in people with Carcinoma, Non-Small-Cell Lung, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Whole body 18F-FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 3 sitesDenmark
- Study dates
- 25 Oct 2018to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Rigshospitalet
Copenhagen, 2100
Gentofte Hospital
Gentofte Municipality, 2900
Herlev Hospital
Herlev, 2730
About this study
Official title: Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial
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
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Whole body 18F-FDG PET/CT
- Keywords
- Positron Emission Tomography Computed Tomography, X-Ray Computed Tomography, Liquid Biopsy, Quality of Life, Medical Oncology, Radiation Oncology, Follow-up
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body 18F-FDG PET/CTDiagnostic test
In the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment. A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment. All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm A, PET/CT | Experimental | 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. Receives: Diagnostic Test: Whole body 18F-FDG PET/CT |
| Control arm B | No intervention | CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of relapses treatable with curative intent
As decided by multidisciplinary meetings
Measured: Until first detected relapse or 2 years after enrollment
Secondary outcomes (12)
Time to verified relapse
Relapse verified by histology or imaging combined with MDM review
Measured: From date of randomization until the date of first documented relapse assessed up to 24 months
Overall survival
Death of any course or censoring
Measured: From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
Overall survival for patients with relapse
Death of any course or censoring
Measured: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Performance status at relapse
Performance status of study participants at relapse will be assessed using Eastern Cooperative Oncology Group (ECOG) performance status scale from grade 0 to grade 4, where grade 0 corresponds to a patient who is "fully active, able to carry on all pre-disease performance without restriction" and grade 4 is a patient who is "completely disabled; cannot carry on any selfcare; totally confined to bed or chair".
Measured: From randomization until first detected relapse or 24 months
Quality of life / QLQ-C30
Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionaire Core Questionaire 30 (EORTC QLQ-C30).
The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").
Measured: From randomization until first detected relapse or 24 months
Quality of life / QLQ-LC13
Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionair Lung Cancer 13 (EORTC QLQ-LC13).
The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").
Measured: From randomization until first detected relapse or 24 months
Quality of life / Raw score
From the results of QLQ-C30 and QLQ-LC13 a Raw Score (RS) is calculated (average of all scores) and Quality of Life is calculated as (RS - 1)/3 which outputs a value between 0 and 1, where 0 is a complete absence of symptoms and 1 is the maximum severity of all related symptoms. This will be used for calculation of QALY in the cost-effectiveness analysis.
Measured: From randomization until first detected relapse or 24 months
Number of procedures to assess incidental findings
Procedures resulting from an incidental finding on a follow up scan
Measured: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Types of procedures to assess incidental findings
Invasive / non-invasive
Measured: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Adverse events due to invasive procedures done to assess incidental findings
For example: Bleeding, pneumothorax, hospital admission
Measured: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Cost-effectiveness analysis of intervention
Cost-effectiveness of the PET/CT regimen vs the CT regimen is assessed with the ICER (incremental cost-effectiveness ratio), i.e. the ratio of net health care costs to net QALYs ( quality-adjusted life years). Net health care costs are estimated as the health care costs difference between the two arms and net QALYs likewise. Health care costs are calculated from register-based information on health care consumption cumulated in 2-yrs follow-up (DRG-rates) supplemented by intervention costs based on project costs. The relevant cost data are available at "Sundhedsdatastyrelsen" using their research service.
Measured: From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
Type of treatment after verification of relapse
Description of treatment - e.g. surgical, radiotherapy, stereotactic ablative body radiotherapy, medical treatment
Measured: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start25 Oct 2018
- Primary completion1 Sep 2023
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Lung Cancer Group, Danish Comprehensive Cancer Center
- Responsible party
- Principal investigator, Barbara Malene Fischer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Barbara M Fischer, MD PhD DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740126
- Sponsor's protocol ID
- H-18009536
- Acronym
- SUPE_R
- Status last verified
- Aug 2026
- First submitted
- 25 Oct 2018
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guldbrandsen 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.
PubMed 41387040Guldbrandsen 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.
PubMed 40258572
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03740126
- Acronym / sponsor ID
- SUPE_R / H-18009536
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Positron Emission Tomography Computed Tomography, X-Ray Computed Tomography, Liquid Biopsy, Quality of Life, Medical Oncology, Radiation Oncology, Follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Lung Cancer Group, Danish Comprehensive Cancer Center
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm A, PET/CT | Experimental | Diagnostic Test: Whole body 18F-FDG PET/CT18F-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. |
| Control arm B | No intervention | –CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body 18F-FDG PET/CTIn the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment. A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment. All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months. | Diagnostic test | Arm A, PET/CT |
Primary outcome
Number of relapses treatable with curative intent
Time frame: Until first detected relapse or 2 years after enrollment
As decided by multidisciplinary meetings
12 secondary outcomes
Time to verified relapse
Time frame: From date of randomization until the date of first documented relapse assessed up to 24 months
Overall survival
Time frame: From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
Overall survival for patients with relapse
Time frame: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Performance status at relapse
Time frame: From randomization until first detected relapse or 24 months
Quality of life / QLQ-C30
Time frame: From randomization until first detected relapse or 24 months
Quality of life / QLQ-LC13
Time frame: From randomization until first detected relapse or 24 months
Quality of life / Raw score
Time frame: From randomization until first detected relapse or 24 months
Number of procedures to assess incidental findings
Time frame: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Types of procedures to assess incidental findings
Time frame: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Adverse events due to invasive procedures done to assess incidental findings
Time frame: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Cost-effectiveness analysis of intervention
Time frame: From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
Type of treatment after verification of relapse
Time frame: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 41387040Guldbrandsen 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.
- Derived from this study: PubMed 40258572Guldbrandsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara M Fischer, MD PhD DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body 18F-FDG PET/CT in people with Carcinoma, Non-Small-Cell Lung, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of relapses treatable with curative intent (time frame: Until first detected relapse or 2 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740126, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.