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

Xiao Chen36 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatic Malignancies

Interventions

FAPI PET/MR combined with gadoxetate disodiumDIAGNOSTIC_TEST

Patients with clinical suspected hepatic malignancies will receive the FAPI PET/MR.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Diagnostic performance

sensitivity, specificity, accuracy, positive and negative predictive values

Time frame: through study completion, an average of 2 years

Secondary Outcomes

Quantitative parameters of PET/MR

the maximum standardized uptake value and tumour-to-background ratios

Time frame: completed within one week after the PET examination

Central Contacts

Xiao Chen, Ph.D

CONTACT

+8615922970174 xiaochen229@foxmail.com

Data from ClinicalTrials.gov

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