Clinical trial · Interventional
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
NCT05687747CI-TRIAL-00088128recruitingPhase 1ClinicalTrials.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)
Single centre prospective evaluation of 68Gallium(Ga68)-FAPI-46 PET/MRI in patients diagnosed with Hepatocellular Carcinoma (HCC). 68Gallium-FAPI-46 PET/MRI and standard contrasted multiphasic MRI imaging will be acquired in patients with radiological or histological diagnosis of HCC. The PET scan results will be compared to standard imaging to evaluate its role in lesion detection, characterisation and staging in patients with HCC.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Gallium-FAPI-46 PET/MRI
- description
- Patients receiving Ga68-FAPI-46 will be injected at a dose of 4mCi +/- 2mCi (0.05mCi/kg). Whole body PET scans will be acquired 45mins post injection from head to mid thighs
- interventionNames
- Drug: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI
Primary outcomes (1)
- measure
- Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison
- timeFrame
- 1 year
- description
- Calculated as: Number of MRI detected HCC lesions with FAPI-46 uptake / number of MRI detected intrahepatic HCC lesions
Secondary outcomes (2)
- measure
- Determine the proportion of cases whereby use of FAPI-46 PET/MRI leds to AJCC TNM/BCLC stage being, i) unchanged, ii) up-staged and iii) down-staged
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21-99 years * Diagnosis of HCC based on histological assessment, or meeting consensus radiological criteria for diagnosis of HCC based on American Association for the Study of Liver Diseases practice guidelines(18) * No prior locoregional therapy for HCC * Creatinine clearance \> 30ml/min based on Cockcroft Gault formula * Able to provide informed signed consent Exclusion Criteria: * Allergy to 68Ga-FAPI contrast agents * Contraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobia * Weight \> 150kg * Known active malignancy other than HCC * Hepatic surgery within the last 30 days. * Active inflammatory conditions that may affect FAPI imaging in opinion of investigator. Including but not limited to active infection, IgG4-related disease, inflammatory bowel disease, * Pregnancy (all women of childbearing age are required to undertake a urine pregnancy test)
References
Publications (17)
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- BACKGROUNDWong S. Update on Positron Emission Tomography for Hepatocellular Carcinoma. Hong Kong J Radiol. 2017;20:192-204.
- BACKGROUNDAertgeerts K, Levin I, Shi L, Snell GP, Jennings A, Prasad GS, Zhang Y, Kraus ML, Salakian S, Sridhar V, Wijnands R, Tennant MG. Structural and kinetic analysis of the substrate specificity of human fibroblast activation protein alpha. J Biol Chem. 2005 May 20;280(20):19441-4. doi: 10.1074/jbc.C500092200. Epub 2005 Apr 4. PMID 15809306
- BACKGROUNDKoustoulidou S, Hoorens MWH, Dalm SU, Mahajan S, Debets R, Seimbille Y, de Jong M. Cancer-Associated Fibroblasts as Players in Cancer Development and Progression and Their Role in Targeted Radionuclide Imaging and Therapy. Cancers (Basel). 2021 Mar 4;13(5):1100. doi: 10.3390/cancers13051100. PMID 33806468
- BACKGROUNDWang XM, Yu DM, McCaughan GW, Gorrell MD. Fibroblast activation protein increases apoptosis, cell adhesion, and migration by the LX-2 human stellate cell line. Hepatology. 2005 Oct;42(4):935-45. doi: 10.1002/hep.20853. PMID 16175601
- BACKGROUNDJu MJ, Qiu SJ, Fan J, Xiao YS, Gao Q, Zhou J, Li YW, Tang ZY. Peritumoral activated hepatic stellate cells predict poor clinical outcome in hepatocellular carcinoma after curative resection. Am J Clin Pathol. 2009 Apr;131(4):498-510. doi: 10.1309/AJCP86PPBNGOHNNL.