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

Not yet recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06520189
• Lead Sponsor: Assiut University

Brief Summary

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-20
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Study Start: 2024-10-01
• Primary Completion: 2028-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Assessment of semi-quantitative F-18 FDG PET/CT as a non-invasive method for prediction of EGFR mutations in lung cancer patients.	baseline	detection value of F-18 FDG PET/CT for the prediction of EGFR mutation in lung cancer patients.

Secondary Outcome Measures

Name	Time	Method
• Assessment of the relationship between degree of the tracer uptake and pathology of the lesion.	baseline	correlate between degree of the tracer uptake and pathology of the lesion