Clinical trial · Observational
Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
NCT06287411CI-TRIAL-00074667unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAPI PET/MR combined with gadoxetate disodium | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic performance
- timeFrame
- through study completion, an average of 2 years
- description
- sensitivity, specificity, accuracy, positive and negative predictive values
Secondary outcomes (1)
- measure
- Quantitative parameters of PET/MR
- timeFrame
- completed within one week after the PET examination
- description
- the maximum standardized uptake value and tumour-to-background ratios
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDGuo 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 33179149