Clinical trial NCT05687747: Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
Official title: Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
68Ga-FAPI-46 PET/MRI
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2023-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: Sensitivity estimation of 68Gallium-FAPI-46 PET/MRI in per-lesion analysis for all lesions with available surgical resection samples for histopathology assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Robert John Walsh
Study officials:
affiliation: National University Hospital, Singapore
name: Robert Walsh
role: PRINCIPAL_INVESTIGATOR
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