Back to resultsComparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
68Ga-FAPI-46
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring 68Ga-FAPI-46, Lung Cancer
Eligibility 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
Sites / Locations
- Department of Nuclear Medicine, Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI-46 PET Scan
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05617742
First Posted
November 8, 2022
Last Updated
September 8, 2023
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05617742
Brief Title
Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
Official Title
68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
68Ga-FAPI-46, Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI-46 PET Scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI-46
Intervention 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
Primary Outcome Measure Information:
Title
To define the diagnostic performance 68Ga-FAPI PET
Description
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.
Time Frame
Through study completion, 2 years
Secondary Outcome Measure Information:
Title
To determine the safety profile of 68Ga-FAPI PET
Description
Number of participants with 68Ga-FAPI-46 PET scan related adverse events assessed by CTCAE v5.0
Time Frame
Up to 7 days post injection with 68Ga-FAPI-46
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kung-Chu Ho, MD
Phone
+886975365783
Email
b8301068@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kung-Chu Ho, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine, Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kung-Chu Ho, MD
Phone
+886975365783
Email
b8301068@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
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