HepaSMART: Hepatocellular Carcinoma Imaging Using PSMA PET/CT
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 18F-DCFPyL Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL |
Drug: 18F-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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female aged 18 years or older at screening
-
Has provided written informed consent for participation in the study
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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
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Patients must be available for follow-up
Exclusion Criteria:
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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
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Any history of prostate cancer or elevated PSA level for male patients
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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
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Participation in another clinical study with an investigational product or another systemic cancer therapy administered in the last 4 weeks
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Has known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study
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Women who are pregnant or lactating
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Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiari syndrome) or cardiac cirrhosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Vincent's Hospital | Fitzroy | Victoria | Australia | 3065 |
| 2 | Austin Health | Heidelberg | Victoria | Australia | 3084 |
| 3 | Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia | 3000 |
| 4 | The Royal Melbourne Hospital | Melbourne | Victoria | Australia |
Sponsors and Collaborators
- Peter MacCallum Cancer Centre, Australia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HREC/62461/PMCC