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[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity

Not Applicable
Recruiting
Conditions
Liver Cancer
Interventions
Diagnostic Test: FAPI PET
Registration Number
NCT05806333
Lead Sponsor
Jilin University
Brief 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
suspicious focal liver mass without FDG avidityFAPI PETExperimental: 18F-FAPI PET/CT Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer
Primary Outcome Measures
NameTimeMethod
Diagnostic performance of FAPI PET1 year

Sensitivity and specificity in detecting liver cancer

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

China-Japan Union Hospital

🇨🇳

Chang chun, Jilin, China

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