Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 68Ga-FAPI-46 PET Scan A single-center prospective interventional single-arm clinical trial. All patients will undergo whole-body 68Ga-FAPI-46 PET scan within two weeks before or after 18F-FDG-PET. Injected activity of 68Ga-FAPI-46 is limited to 100-250 MBq per examination. |
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Nuclear Medicine, Chang Gung Memorial Hospital | Taoyuan | Taiwan |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Principal Investigator: Kung-Chu Ho, MD, Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202101258A0