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

NCT05260606 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-04-17

No results posted yet for this study

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

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Immune Checkpoint Inhibitors

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.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • hoyun lee, M.D., Ph.D. · Samsung Medical Center, Department radiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260606 on ClinicalTrials.gov