Clinical trial NCT06287411: Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
Official title: Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatic Malignancies
Keywords: hepatic malignancies
FAPI
PET/MR
gadoxetate disodium
FDG
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects the investigators selected are adults who are not restricted by gender.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Quantitative parameters of PET/MR
timeFrame: completed within one week after the PET examination
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital, Army Medical University
name: Xiao Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo W, Pang Y, Yao L, Zhao L, Fan C, Ke J, Guo P, Hao B, Fu H, Xie C, Lin Q, Wu H, Sun L, Chen H. Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1604-1617. doi: 10.1007/s00259-020-05095-0. Epub 2020 Nov 11.