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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Hepatic Malignancies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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FAPI PET/MR combined with gadoxetate disodium

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No