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RecruitingNCT06287411Updated Mar 5, 2024

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

An observational study in Hepatic Malignancies, sponsored by Xiao Chen. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Xiao Chen · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Hepatic Malignancies

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Keywords

  • hepatic malignancies
  • FAPI
  • PET/MR
  • gadoxetate disodium
  • FDG
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 36 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Xiao Chen is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The subjects the investigators selected are adults who are not restricted by gender.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
36 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testFAPI PET/MR combined with gadoxetate disodium

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

06

What researchers measure

Primary outcomes

  1. Diagnostic performance

    sensitivity, specificity, accuracy, positive and negative predictive values

    Time frame: through study completion, an average of 2 years

Secondary outcomes

  1. Quantitative parameters of PET/MR

    the maximum standardized uptake value and tumour-to-background ratios

    Time frame: completed within one week after the PET examination

07

Study locations

1 of 1 sites recruiting
  • Department of Nuclear Medicine, Daping Hospital of Army Medical University
    Chongqing, Chongqing 400010, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33179149 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06287411
Lead sponsor
Xiao Chen
Responsible party
Xiao Chen (Director of Nuclear Medicine Department, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University) — Sponsor-investigator
First posted
Mar 1, 2024
Start date
Dec 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 5, 2024

Study contacts

Xiao Chen, Ph.D
Contact
xiaochen229@foxmail.com
+8615922970174
Xiao Chen, Ph.D
principal investigator · Daping Hospital, Army Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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