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

Phase 1

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI

• Registration Number: NCT05687747
• Lead Sponsor: National University Hospital, Singapore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-18
• Study Start: 2023-08-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Gallium-FAPI-46 PET/MRI	Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI	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

Primary Outcome Measures

Name	Time	Method
Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison	1 year	Calculated as: Number of MRI detected HCC lesions with FAPI-46 uptake / number of MRI detected intrahepatic HCC lesions

Secondary Outcome Measures

Name	Time	Method
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	1 year	Calculated as: number of HCC lesions identified on standard of care imaging with FAPI-46 uptake / total number of HCC lesions on standard of care imaging
Sensitivity estimation of 68Gallium-FAPI-46 PET/MRI in per-lesion analysis for all lesions with available surgical resection samples for histopathology assessment	1 year	Calculated as: Number of pathologically confirmed HCC lesions identified on FAPI PET/MRI / total number of pathological confirmed HCC lesions

Trial Locations

Locations (1)

Robert John Walsh; 🇸🇬 Singapore, Singapore