Hepatocellular Carcinoma Imaging Using PSMA PET/CT (HepaSMART)

August 16, 2026 updated by: Peter MacCallum Cancer Centre, Australia

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Research Manager
  • Phone Number: +61 3 8559 6602

Study Locations

  • Australia
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia
        • The Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
True Positive Rate per patient
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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.
Time Frame: 6 months
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PSMA uptake
Time Frame: 6 months
Qualitative uptake of PSMA measured on a per lesion basis.
6 months
Maximum standard uptake value
Time Frame: 6 months
Maximum standard uptake value of lesions on PSMA PET/CT.
6 months
CT LIRADS (Liver Imaging Reporting and Data System) Score
Time Frame: 6 months
LI RADS Score for CT lesions.
6 months
PSMA expression.
Time Frame: 6 months
Expression of PSMA per lesion.
6 months
GLUT-1 expression
Time Frame: 6 months
Expression of GLUT 1 per lesion.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peter MacCallum Cancer Centre, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREC/62461/PMCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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