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

Xiao Chen

Status: Enrolling

Conditions: Hepatic Malignancies

Treatments: Diagnostic Test: FAPI PET/MR combined with gadoxetate disodium

Study type: Observational

Funder types: Other

Identifiers

NCT06287411

202436

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient ≥ 18 years of age at the time of consent;
2. Patients with suspected, newly diagnosed, or previously treated liver cancer;
3. Estimated creatinine clearance > 30ml/min;
4. Provided written informed consent authorisation before participating in the study.

Exclusion criteria

1. Allergic to the gadoxetate disodium；
2. MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;
3. Weight > 90Kg;
4. Pregnancy or lactation;
5. Active inflammation may affect FAPI imaging.