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NCT05687747
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 21 Years – 99 Years
Phase: PHASE1
Enrollment: 100
Sponsor: National University Hospital, Singapore
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age 21-99 yearsDiagnosis 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 HCCCreatinine clearance > 30ml/min based on Cockcroft Gault formulaAble to provide informed signed consentExclusion Criteria:Allergy to 68Ga-FAPI contrast agentsContraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobiaWeight > 150kgKnown active malignancy other than HCCHepatic 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)
Source: ClinicalTrials.gov (NCT05687747). StuddyBuddy aggregates publicly available trial information.