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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05806333
Enrollment
60
Registered
2023-04-10
Start date
2022-06-01
Completion date
2023-06-01
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

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.

Interventions

DIAGNOSTIC_TESTFAPI PET

Drug: 18F-FAPI 18F-FAPI were injected into the patients before the PET/CT scans

Sponsors

Jilin University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance of FAPI PET1 yearSensitivity and specificity in detecting liver cancer

Countries

China

Contacts

Primary ContactShi Gao [gshi]
Gaoshi@jlu.edu.cn+86-84995467
Backup ContactJi Bin [jbin]
jibin1983104@163.com+86-15143066521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026