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Not yet recruiting NCT06520189

Value of F-18 FDG PET/CT for the Prediction of EGFR Mutation in Lung Cancer Patients

— Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: F-18 FDGPET/CT.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To detect value of F-18FDG PET/CT as a non-invasive method for the prediction of EGFR mutations in lung cancer patients.

Detailed description

* Globally, lung cancer cases and deaths are rising. In 2018, GLOBOCAN estimated 2.09 million new cases (11.6% of total cancer cases) and 1.76 million deaths (18.4% of total cancer deaths). It is the most frequent cancer and cause of cancer death in men. * Epidermal growth factor receptor (EGFR) mutations are the second most common oncogenic driver event in non-small cell lung cancer (NSCLC) and classical activating mutations are well defined as strong predictors for good clinical response to EGFR tyrosine kinase inhibitors (EGFRi). * Over the last decade, the introduction of tyrosine-kinase inhibitors (TKIs) has showed a remarkable paradigm shift in the treatment of non-small cell lung cancer (NSCLC). However, genetic testing is sometimes unavailable. * Data from previous studies that have investigated the value of F-18 FDG PET/CT for predicting EGFR status are conflicting.

Interventions

  • Device F-18 FDGPET/CT
    F-18 FDGPET/CT oncology protocol for lung cancer patients

Primary outcome measures

  • • Assessment of semi-quantitative F-18 FDG PET/CT as a non-invasive method for prediction of EGFR mutations in lung cancer patients. [Time frame: baseline]
Secondary outcome measures (1)
  • • Assessment of the relationship between degree of the tracer uptake and pathology of the lesion. [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • NSCLC patients who underwent EGFR mutation testing.
  • All patients ≥ 18 years.

Exclusion criteria

  • Time interval between EGFR sampling and PET/CT more than 1 month.
  • Patients had been treated before sampling for the gene alteration analysis
  • Patients with glucose level < 200 mg/dl.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Bade BC, Dela Cruz CS. Lung Cancer 2020: Epidemiology, Etiology, and Prevention. Clin Chest Med. 2020 Mar;41(1):1-24. doi: 10.1016/j.ccm.2019.10.001. PMID 32008623
  • Harrison PT, Vyse S, Huang PH. Rare epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer. Semin Cancer Biol. 2020 Apr;61:167-179. doi: 10.1016/j.semcancer.2019.09.015. Epub 2019 Sep 25. PMID 31562956
  • Lv Z, Fan J, Xu J, Wu F, Huang Q, Guo M, Liao T, Liu S, Lan X, Liao S, Geng W, Jin Y. Value of 18F-FDG PET/CT for predicting EGFR mutations and positive ALK expression in patients with non-small cell lung cancer: a retrospective analysis of 849 Chinese patients. Eur J Nucl Med Mol Imaging. 2018 May;45(5):735-750. doi: 10.1007/s00259-017-3885-z. Epub 2017 Nov 21. PMID 29164298
  • Huang CT, Yen RF, Cheng MF, Hsu YC, Wei PF, Tsai YJ, Tsai MF, Shih JY, Yang CH, Yang PC. Correlation of F-18 fluorodeoxyglucose-positron emission tomography maximal standardized uptake value and EGFR mutations in advanced lung adenocarcinoma. Med Oncol. 2010 Mar;27(1):9-15. doi: 10.1007/s12032-008-9160-1. Epub 2009 Jan 7. PMID 19130320

Identifiers

NCT: NCT06520189 · F-18 FDG PET/CT and EGFR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗