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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05617742

Enrollment

Registered

2022-11-15

Start date

2022-12-01

Completion date

2026-01-31

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

68Ga-FAPI-46, Lung Cancer

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TEST68Ga-FAPI-46

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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 CT planned to have biopsy or surgery 4. Patients scheduled to undergo FDG-PET examination 5. Performance status: 0, 1, 2, 3

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 with study entry 5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent

Design outcomes

Primary

Measure	Time frame	Description
To define the diagnostic performance 68Ga-FAPI PET	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

Measure	Time frame	Description
To determine the safety profile of 68Ga-FAPI PET	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

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATORKung-Chu Ho, MD

Chang Gung Memorial Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026