The purpose of this study is to evaluate the use of multiparametric dynamic whole-body \[68Ga\]Ga-PSMA PET/CT imaging in newly diagnosed HCC patients or in HCC patients with recent suspicion of refractory, residual, or recurrent disease.
Provided written informed consent
Patient aged ≥ 18 years
For cohort A: patient with HCC histologically proven or who meet radiological criteria and are scheduled for biopsy For cohort B: patient with known HCC requiring a new diagnostic imaging workup for suspected refractory, residual or recurrent disease
Presence of at least one morphological evaluable lesion according to mRECIST 1.1 using contrast CT/MRI
Known hypersensitivity to PSMA-11, to any excipient or derivative or to radiographic contrast agents
Patient requiring emergent surgery for a ruptured / bleeding HCC
Radioembolization within 3 months prior to inclusion
Cardiac disease with New York Heart Association classification of III or IV
Single group
[68Ga]Ga-PSMA-11
RadiationDynamic whole-body \[68Ga\]Ga-PSMA acquisition to HCC patients
Diagnostic performance
Sensitivity of qualitative assessment of dynamic whole-body \[68Ga\]Ga- PSMA PET/CT using standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months as gold standard in two populations of HCC patients: at the time of initial diagnosis or upon detection of suspected refractory, residual, or recurrent relapse.
Kinetic parameters
Patlak's parametric reconstruction, which estimates the 68 Gallium blood input function from the image, will be employed to extract the Ki absorption coefficient.
Diagnostic performance of multiparametric image evaluation approach at the lesion level
Sensitivity value of D-WB \[68Ga\]Ga-PSMA PET/CT and gold standard will be calculated and compared at the lesion level.
Diagnostic performance of multiparametric image evaluation approach at the patient level
Sensitivity value of static \[68Ga\]Ga-PSMA PET/CT and Choline-PET will be calculated and compared.
Diagnostic performance of multiparametric image evaluation approach at the patient level
Sensitivity value of dynamic \[68Ga\]Ga-PSMA PET/CT and Choline-PET will be calculated and compared.
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