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

NCT03740126 | Active Not Recruiting DMC

• 1 other identifier: H-18009536
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 3

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

Keywords

Positron Emission Tomography Computed Tomography; X-Ray Computed Tomography; Liquid Biopsy; Quality of Life; Medical Oncology; Radiation Oncology; Follow-up

Outcome Measures

Primary Outcomes (1)

• Number of relapses treatable with curative intent

  As decided by multidisciplinary meetings

  Until first detected relapse or 2 years after enrollment

Secondary Outcomes (12)

• Time to verified relapse

  From date of randomization until the date of first documented relapse assessed up to 24 months

• Overall survival

  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

  From randomization until 12 months after first detected relapse or until death (whichever comes first)

• Performance status at relapse

  From randomization until first detected relapse or 24 months

• Quality of life / QLQ-C30

  From randomization until first detected relapse or 24 months

Study Arms (2)

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.

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.

Interventions

Whole body 18F-FDG PET/CT 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.

Arm A, PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Lung Cancer Group: collaborator
• Danish Comprehensive Cancer Center: collaborator

Study Sites (3)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Gentofte Hospital

Gentofte Municipality, 2900, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (2)

• 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. 2025 Nov 19:S1525-7304(25)00319-5. doi: 10.1016/j.cllc.2025.11.011. Online ahead of print.

  PMID: 41387040 DERIVED

• 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.

  PMID: 40258572 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Barbara M Fischer, MD PhD DMSci

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Professor

Model Details: Multicenter, randomized controlled trial

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 14, 2018
• Study Start: October 25, 2018
• Primary Completion: September 1, 2023
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

DK (3)