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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806333
• Other study ID #: ChinaJapanUH
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: Jilin University
• Contact: Shi Gao [gshi]
• Phone: +86-84995467
• Email: Gaoshi[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	China-Japan Union Hospital	Chang chun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of FAPI PET	Sensitivity and specificity in detecting liver cancer	1 year