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

Recruiting

• Conditions: Hepatic Malignancies

• Registration Number: NCT06287411
• Lead Sponsor: Xiao Chen

Brief 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).

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Status Verified: 2024-03
• Study First Posted: 2024-03-01
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	through study completion, an average of 2 years	sensitivity, specificity, accuracy, positive and negative predictive values

Secondary Outcome Measures

Name	Time	Method
Quantitative parameters of PET/MR	completed within one week after the PET examination	the maximum standardized uptake value and tumour-to-background ratios

Trial Locations

Locations (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China