NCT06287411

Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Xiao Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards.

Detailed description

1. Clinical and biological data, including the course of disease, underlying liver disease (hepatitis or cirrhosis), serum alpha-fetoprotein, carcinoembryonic antigen and carbohydrate antigen 19-9 levels were collected from each patient. 2. PET image analysis: Each patient underwent both FAPI and fluorodeoxyglucose (FDG) PET/MR, including T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), apparent diffusion coefficient (ADC) and gadoxetate disodium-enhanced MRI. Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the target-to-background ratio (TBR) which was calculated by dividing the SUVmax of the lesion by the background SUVmean obtained from nontumor liver tissue. 3. Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of glucose transporter-1 (GLUT-1) and fibroblast activation protein (FAP).

Conditions

• Hepatic Malignancies

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FAPI PET/MR combined with gadoxetate disodium	Patients with clinical suspected hepatic malignancies will receive the FAPI PET/MR.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-03-01
• Last updated: 2024-03-05

Locations

1 site across 1 country: China