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Hepatocellular Carcinoma Imaging Using PSMA PET/CT

PHASE2RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-09-08

Primary completion: 2024-03-08

Study completion finish: 2024-09-08

Study type

DIAGNOSTIC

Phase

PHASE2

Trial ID

NCT05095519

Intervention or treatment

DRUG: 18F-DCFPyL

Conditions

• Hepatocellular Carcinoma

Image related to Hepatocellular Carcinoma

Condition: Hepatocellular Carcinoma
DRUG: 18F-DCFPyL
Heidelberg, Victoria, Australia and more
Sponsor: Peter MacCallum Cancer Centre, Australia

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Health

Research sites nearby

Select from list below to view details:

Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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
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
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
PSMA uptake	Qualitative uptake of PSMA measured on a per lesion basis.	6 months
Maximum standard uptake value	Maximum standard uptake value of lesions on PSMA PET/CT.	6 months
CT LIRADS (Liver Imaging Reporting and Data System) Score	LI RADS Score for CT lesions.	6 months
PSMA expression.	Expression of PSMA per lesion.	6 months
GLUT-1 expression	Expression of GLUT 1 per lesion.	6 months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Hepatocellular Carcinoma Imaging Using PSMA PET/CT