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NCT Number: NCT06520189

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

F-18 FDGPET/CT

Device

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

Primary outcomes

  1. • 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

    detection value of F-18 FDG PET/CT for the prediction of EGFR mutation in lung cancer patients.

Secondary outcomes

  1. • Assessment of the relationship between degree of the tracer uptake and pathology of the lesion.

    Time frame: baseline

    correlate between degree of the tracer uptake and pathology of the lesion

Study contacts

Contact information is provided by the study sponsor or research team.

Nahla Moustafa Mahmoud, Assistant professor

CONTACT

[email protected]

01009466255

walaa Gamal Fathy, assistant lecturer

CONTACT

[email protected]

01503995795

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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