Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, PSMA, 18F-DCFPyL
Brief summary
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).
Detailed description
A total of 30 patients will be recruited in this prospective pilot study who have HCC on imaging criteria (LI-RADS 5) for surgical resection, or patients with indeterminate liver lesions (LI-RADS 3 or 4) planned for liver biopsy. 18F-DCFPYL PSMA PET/CT will be performed prior to the planned surgery or liver biopsy
Interventions
DRUG18F-DCFPyL
18F-DCFPyL will be administered with a single dose of 3.5 MBq per kg (2-4 MBq per kg), maximum 400 MBq), administered as a slow (over 30 seconds) intravenous injection
Sponsors
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years or older at screening * Has provided written informed consent for participation in the study * Must have risk factors for HCC e.g. cirrhosis, chronic hepatitis B infection with or without cirrhosis * 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 willing and able to comply with the protocol and procedures for the duration of the study * Patients must be available for follow-up
Exclusion criteria
* Abdominal surgery or radiotherapy to the abdomen within \<4 weeks of registration. Patients must have recovered from any effects of any major surgery * Uncontrolled intercurrent illness that is likely to impede participation and or compliance * Any history of prostate cancer or elevated PSA level for male patients * Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ * 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 * Women who are pregnant or lactating * Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiari syndrome) or cardiac cirrhosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True Positive Rate per patient | 6 months | The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis. |
| True Negative Rate per patient | 6 months | The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis. |
| True Positive Rate per lesion | 6 months | The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis. |
| True Negative Rate per lesion. | 6 months | The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSMA uptake | 6 months | Qualitative uptake of PSMA measured on a per lesion basis. |
| Maximum standard uptake value | 6 months | Maximum standard uptake value of lesions on PSMA PET/CT. |
| CT LIRADS (Liver Imaging Reporting and Data System) Score | 6 months | LI RADS Score for CT lesions. |
| PSMA expression. | 6 months | Expression of PSMA per lesion. |
| GLUT-1 expression | 6 months | Expression of GLUT 1 per lesion. |
Countries
Australia
Outcome results
None listed