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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617742
• Other study ID #: 202101258A0
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: Kung-Chu Ho, MD
• Phone: +886975365783
• Email: b8301068[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• 68Ga-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

Locations

Country	Name	City	State
Taiwan	Department of Nuclear Medicine, Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the diagnostic performance 68Ga-FAPI PET	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.	Through study completion, 2 years
Secondary	To determine the safety profile of 68Ga-FAPI PET	Number of participants with 68Ga-FAPI-46 PET scan related adverse events assessed by CTCAE v5.0	Up to 7 days post injection with 68Ga-FAPI-46