Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy

NCT ID: NCT03740126

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2026-08-31

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm A, PET/CT

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.

Group Type: EXPERIMENTAL

Whole body 18F-FDG PET/CT

Intervention Type: DIAGNOSTIC_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.

Control arm B

CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Whole body 18F-FDG PET/CT

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Lung Cancer Group

OTHER

Sponsor Role: collaborator

Danish Comprehensive Cancer Center

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Barbara Malene Fischer

Senior Consultant, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara M Fischer, MD PhD DMSci

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Gentofte Hospital

Gentofte Municipality, , Denmark

Herlev Hospital

Herlev, , Denmark

Countries

Denmark

References

Guldbrandsen 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.

Reference Type: DERIVED

PMID: 40258572 (View on PubMed)

Other Identifiers

H-18009536

Identifier Type: -

Identifier Source: org_study_id