Clinical Trial · NCT05687747

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

Overview

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.

Sponsor

National University Hospital, Singapore

Phase

Phase 1

Contacts

Robert Walsh (PRINCIPAL_INVESTIGATOR)

Robert Walsh (CONTACT)

robert_walsh@nuhs.edu.sg

6908-2222

ClinicalTrials.gov

NCT05687747

Drug / Compound

FAPI-46

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

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

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,
Known active malignancy other than HCC
Weight \> 150kg
Allergy to 68Ga-FAPI contrast agents
Contraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobia