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

National University Health System (NUHS)

Status and phase: Enrolling; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05687747

2022/00487

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

68Gallium-FAPI-46 PET/MRI

Experimental group

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

Treatment:

Drug: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI