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

NCT05687747 | Recruiting Phase 1

• 1 other identifier: 2022/00487
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; 68Ga-FAPI-46 PET/MRI

Outcome Measures

Primary Outcomes (1)

• Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison

  Calculated as: Number of MRI detected HCC lesions with FAPI-46 uptake / number of MRI detected intrahepatic HCC lesions

  1 year

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

68Gallium-FAPI-46 PET/MRI

EXPERIMENTAL

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

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

Interventions

Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI DRUG

68Gallium-FAPI-46 PET/MRI is a novel radioactive diagnostic tracer used with Positron Emission Tomography imaging. It defects Fibroblast Activation Protein positive cancer cells and cancer associated fibroblasts.

68Gallium-FAPI-46 PET/MRI

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

Robert John Walsh

Singapore, 119074, Singapore

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Robert Walsh

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Walsh

CONTACT

6908-2222; robert_walsh@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: August 18, 2023
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)