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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06287411

Enrollment

Registered

2024-03-01

Start date

2023-12-01

Completion date

2025-12-31

Last updated

2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Malignancies

Keywords

hepatic malignancies, FAPI, PET/MR, gadoxetate disodium, FDG

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).

Interventions

DIAGNOSTIC_TESTFAPI PET/MR combined with gadoxetate disodium

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactXiao Chen, Ph.D

xiaochen229@foxmail.com+8615922970174

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026