Hepatocellular Carcinoma Imaging Using PSMA PET/CT

Hepatocellular Carcinoma Clinical Trial

— HepaSMART  

Official title:

Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05095519
• Other study ID #: HREC/62461/PMCC
• Status: Recruiting
• Phase: Phase 2
• Start date: September 8, 2021
• Est. completion date: September 8, 2024

Study information

• Verified date: March 2024
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: Grace Kong
• Phone: +61 3 85595000
• Email: NMResearch[@]petermac.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 8, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True Positive Rate per patient	The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.	6 months
Primary	True Negative Rate per patient	The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.	6 months
Primary	True Positive Rate per lesion	The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.	6 months
Primary	True Negative Rate per lesion.	The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.	6 months
Secondary	PSMA uptake	Qualitative uptake of PSMA measured on a per lesion basis.	6 months
Secondary	Maximum standard uptake value	Maximum standard uptake value of lesions on PSMA PET/CT.	6 months
Secondary	CT LIRADS (Liver Imaging Reporting and Data System) Score	LI RADS Score for CT lesions.	6 months
Secondary	PSMA expression.	Expression of PSMA per lesion.	6 months
Secondary	GLUT-1 expression	Expression of GLUT 1 per lesion.	6 months