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Clinical Trial · NCT05095519
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
Overview
The purpose of the research is to evaluate the use of a PSMA PET/CT (Prostate Specific Membrane Antigen Positron Emission Tomography/Computerized Tomography) scan in the diagnosis of HCC (hepatocellular carcinoma) and comparing it to standard scanning techniques with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging).
Drug / Compound
DCFPyL
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PSMA
Ligand Class: Small Molecules
Eligibility
Inclusion
- Patients must be willing and able to comply with the protocol and procedures for the duration of the study
- Patients with liver lesions ≥1 cm suspicious for HCC but with indeterminate features on CT and MRI meeting LI-RADS 3 or 4 criteria planned for biopsy, OR patients with liver lesions diagnostic of HCC based on CT or MRI meeting LI-RADS 5 criteria planned for surgical resection
- Patients must be available for follow-up
- Must have risk factors for HCC e.g. cirrhosis, chronic hepatitis B infection with or without cirrhosis
Exclusion
- Abdominal surgery or radiotherapy to the abdomen within \<4 weeks of registration. Patients must have recovered from any effects of any major surgery
- Women who are pregnant or lactating
- Participation in another clinical study with an investigational product or another systemic cancer therapy administered in the last 4 weeks
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study
- Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiari syndrome) or cardiac cirrhosis
- Uncontrolled intercurrent illness that is likely to impede participation and or compliance
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