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

Hepatic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287411
• Other study ID #: 202436
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Xiao Chen, Ph.D
• Phone: +8615922970174
• Email: xiaochen229[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Malignancies
• Neoplasms

Intervention

Diagnostic Test:
• FAPI PET/MR combined with gadoxetate disodium
Patients with clinical suspected hepatic malignancies will receive the FAPI PET/MR.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Daping Hospital of Army Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xiao Chen

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance	sensitivity, specificity, accuracy, positive and negative predictive values	through study completion, an average of 2 years
Secondary	Quantitative parameters of PET/MR	the maximum standardized uptake value and tumour-to-background ratios	completed within one week after the PET examination