Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
1 other identifier
observational
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 23, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 5, 2024
March 1, 2024
2.1 years
February 23, 2024
March 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic performance
sensitivity, specificity, accuracy, positive and negative predictive values
through study completion, an average of 2 years
Secondary Outcomes (1)
Quantitative parameters of PET/MR
completed within one week after the PET examination
Interventions
Patients with clinical suspected hepatic malignancies will receive the FAPI PET/MR.
Eligibility Criteria
The subjects the investigators selected are adults who are not restricted by gender.
You may qualify if:
- Patient ≥ 18 years of age at the time of consent;
- Patients with suspected, newly diagnosed, or previously treated liver cancer;
- Estimated creatinine clearance \> 30ml/min;
- Provided written informed consent authorisation before participating in the study.
You may not qualify if:
- Allergic to the gadoxetate disodium；
- MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;
- Weight \> 90Kg;
- Pregnancy or lactation;
- Active inflammation may affect FAPI imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiao Chenlead
Study Sites (1)
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400010, China
Related 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.
PMID: 33179149BACKGROUND
Biospecimen
histopathological findings obtained from biopsy or resected surgical specimens
Study Officials
- PRINCIPAL INVESTIGATOR
Xiao Chen, Ph.D
Daping Hospital, Army Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Nuclear Medicine Department
Study Record Dates
First Submitted
February 23, 2024
First Posted
March 1, 2024
Study Start
December 1, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
March 5, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share