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Trial Title:
18F-FAPI and 18F-FDG PET/CT in Patients With Various Types of Cancer
NCT ID:
NCT05485792
Condition:
Cancer
Conditions: Official terms:
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Subjects with various types of cancer undergo contemporaneous 18F-FAPI and 18F-FDG PET/CT
either for an initial assessment or for recurrence detection.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F-FAPI PET/CT and 18F-FDG PET/CT
Description:
Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week
Arm group label:
18F-FAPI PET/CT
Summary:
FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial
carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown
promising diagnostic value in many types of tumors. However, there are currently no
studies on head-to-head comparison of diagnosis value of various types of cancer in
18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate
the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG
PET/CT.
Detailed description:
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl
peptidase-IV (DPP-IV) family located in fibroblast membranes. FAP is overexpressed in the
cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas, including primary and
metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a
promising approach for the visualization of CAFs. CAFs are crucial component of tumor
stroma, promote the growth of cancer cells and are associated with poor prognosis.
Currently, Gallium 68 (68Ga)-fibroblast activation protein inhibitor (FAPI) has shown
promising diagnostic value in many types of tumors, including lung cancer, gastric
carcinomas, peritoneal carcinomas. However, there are currently no studies on
head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and
18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of
18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. adult patients (aged 18 years or order);
2. patients with suspected or newly diagnosed or previously treated malignant tumors
(supporting evidence may include CT, MRI and pathology report);
3. patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans;
4. patients who were able to provide informed consent (signed by participant, parent or
legal representative) and assent according to the guidelines of the Clinical
Research Ethics Committee.
Exclusion Criteria:
1. patients with non-malignant lesions;
2. patients with pregnancy;
3. the inability or unwillingness of the research participant, parent or legal
representative to provide written informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
August 1, 2022
Completion date:
December 30, 2023
Lead sponsor:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Source:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05485792