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Trial Title:
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
NCT ID:
NCT05687747
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
FAPI-46
Conditions: Keywords:
Hepatocellular Carcinoma
68Ga-FAPI-46 PET/MRI
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI
Description:
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.
Arm group label:
68Gallium-FAPI-46 PET/MRI
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
21 Years
Maximum age:
99 Years
Healthy volunteers:
No
Start date:
January 2023
Completion date:
December 2025
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Collaborator:
Agency:
National University of Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687747
