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Completed

NCT Number: NCT05617742

Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer

This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nuclear Medicine, Chang Gung Memorial Hospital

Taoyuan, Taiwan

About this study

FDG-PET imaging is recommended by clinical guidelines for staging of lung cancer; however, there are still limitations of FDG-PET in lung cancer staging due to false-positive and false-negative findings. 68Ga-FAPI PET images have shown high diagnostic performance with high tumor-to-background ratio in various cancers. The purpose of this study is head-to-head comparison of 68Ga-FAPI-46 PET and 18F-FDG PET for the diagnosis and staging or re-staging of lung cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 20 years
  • Informed consent obtained from patients and families
  • Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
  • Patients scheduled to undergo FDG-PET examination
  • Performance status: 0, 1, 2, 3

Exclusion criteria

  • Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
  • Patients with mainly malignant pleural effusion without other measurable lesions
  • Undergoing irradiation at accrual
  • Active infection or other serious underlying medical conditions not compatible with study entry
  • History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent

Treatment and study plan

68Ga-FAPi-46

Diagnostic Test

68Ga-FAPI-46 is a radioactive diagnostic agent for PET imaging in the detection of Fibroblast Activation Protein (FAP) positive tumor cells in cancer patients

Primary outcomes

  1. To define the diagnostic performance 68Ga-FAPI PET

    Time frame: Through study completion, 2 years

    To evaluate the diagnostic performance (sensitivity, specificity, accuracy) of the 68Ga-FAPI-46 PET scan for identification and staging of lung cancer with comparison to 18F-FDG PET. Histopathology and clinical follow-up will be used as truth standard.

Secondary outcomes

  1. To determine the safety profile of 68Ga-FAPI PET

    Time frame: Up to 7 days post injection with 68Ga-FAPI-46

    Number of participants with 68Ga-FAPI-46 PET scan related adverse events assessed by CTCAE v5.0

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2022
Registry last updated
May 13, 2026

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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