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RECRUITING
NCT05260606

Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

Summary

1. Hypothesis : imaging biomarkers of tumor measured by F-18 fluorodeoxyglucose (FDG) positron emission tomography(PET)/computed tomography(CT) is correlated with immune checkpoint inhibitor (ICI) treatment response and patient prognosis. 2. Purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and clinical outcomes in patients with non-small cell lung cancer treated with ICIs. 3. Study subject: patients with non-small cell lung cancer who will be treated with ICIs. 4. Study design: prospective observational study 5. Intervention: F-18 FDG PET/CT

Official title: Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer: Prospective Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2022-05-09

Completion Date

2025-12

Last Updated

2024-04-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

F-18 FDG PET/CT

1. 1st scan: pre-Tx, ICI Tx must be started within 35 days after 1st scan. 2. 2nd scan: interim * Pembrolizumab or atezolizumab: after the 2nd Tx cycle to before the start of the 3rd Tx cycle * Nivolumab: after the 3rd Tx cycle to before the start of the 4th Tx cycle 3. 3rd scan: optional (3rd scan can be performed when disease progression is suspected) 4. Imaging * Fasting: at least 6 hours * Blood glucose level: \< 200 mg/dL * F-18 FDG 0.14 mCi/kg (IV) * Image acquisition: 1 hr after FDG injection, CT images are acquired. After CT scan, PET images are acquired and attenuation-corrected PET images are reconstructed based on the CT image data. * PET/CT: Discovery MIDR or MI (GE Healthcare, Chicago, Illinois, USA) * First and second scans have to be performed with same scan.

Locations (1)

Samsung Medical Center

Seoul, South Korea