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Trial Title:
[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
NCT ID:
NCT05806333
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
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:
FAPI PET
Description:
Drug: 18F-FAPI 18F-FAPI were injected into the patients before the PET/CT scans
Arm group label:
suspicious focal liver mass without FDG avidity
Summary:
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl
peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the
cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary
and metastatic liver cancer. We aim to conduct a prospective study to investigate the
diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG
avidity.
Detailed description:
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl
peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the
cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary
and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be
considered a promising approach for visualizing CAFs. CAFs are crucial components of the
tumor stroma, promote the growth of cancer cells, and are associated with poor prognosis.
Currently, 18F-labelled fbroblast activation protein inhibitor 18F-FAPI has shown
promising diagnostic value in many types of tumors, especially those in which are not
avid for 18F-FDF , and several studies have demonstrated that 18F-FAPI PET/CT is superior
to 18F-FDG PET/CT for detecting liver cancer and has lower tracer uptake in normal liver
tissue. We aim to conduct a prospective study to investigate the diagnostic performance
of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients with suspected liver malignant lesions based on traditional diagnostic
imaging (CT or MRI or ultrasound) and clinical symptoms;
- patients underwent [18F]FDG PET/CT with negative findings (suspicious primary and/or
metastatic lesions were hypo- or isometabolic on [18F]FDG PET/CT);
- patients who agreed to undergo [18F]FAPI PET/CT scans within 1 week.
Exclusion Criteria:
- pregnancy;
- age<18 years old;
- patients with chemo/radio/targeted therapy before scanning;
- inability to provide informed consent (signed by participant, parent, or legal
representative).
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China-Japan Union Hospital
Address:
City:
Chang chun
Zip:
130031
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Wei
Phone:
+8684995117
Email:
Weijunsy1949@163.com
Start date:
June 1, 2022
Completion date:
June 1, 2023
Lead sponsor:
Agency:
Jilin University
Agency class:
Other
Source:
Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806333
