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Trial Title:
Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
NCT ID:
NCT05617742
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
FAPI-46
Conditions: Keywords:
68Ga-FAPI-46
Lung Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-FAPI-46
Description:
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
Arm group label:
68Ga-FAPI-46 PET Scan
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, Chang Gung Memorial Hospital
Address:
City:
Taoyuan
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Kung-Chu Ho, MD
Phone:
+886975365783
Email:
b8301068@gmail.com
Start date:
April 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05617742
