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

Last updated: May 10, 2026
Sponsor: Chang Gung Memorial Hospital
Overall Status: Completed

Phase

N/A

Condition

Lung Cancer

Lung Disease

Non-small Cell Lung Cancer

Treatment

68Ga-FAPI-46

Clinical Study ID

NCT05617742
202101258A0
  • Ages > 20
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 20 years

  2. Informed consent obtained from patients and families

  3. Patients with histology confirmed lung cancer or patients with GGO on chest CTplanned to have biopsy or surgery

  4. Patients scheduled to undergo FDG-PET examination

  5. Performance status: 0, 1, 2, 3

Exclusion

Exclusion Criteria:

  1. Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients

  2. Patients with mainly malignant pleural effusion without other measurable lesions

  3. Undergoing irradiation at accrual

  4. Active infection or other serious underlying medical conditions not compatible withstudy entry

  5. History of significant neurological or psychiatric disorders including dementia thatwould prohibit the understanding and giving of informed consent

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: 68Ga-FAPI-46
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
January 31, 2026

Study Description

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.

Connect with a study center

  • Department of Nuclear Medicine, Chang Gung Memorial Hospital

    Taoyuan,
    Taiwan

    Site Not Available

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