Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, 68Ga-FAPI-46 PET/MRI
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.
Interventions
DRUGRadiolabelled tracer, 68Gallium-FAPI-46 PET/MRI
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.
Sponsors
National University of Singapore
National University Hospital, Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Singapore
Contacts
Primary ContactRobert Walsh
Outcome results
None listed