Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborator: National University, Singapore
• Treatments: FAPI-46

Criteria

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)