Hepatocellular Carcinoma Imaging Using PSMA PET/CT

Last updated: March 14, 2024
Sponsor: Peter MacCallum Cancer Centre, Australia
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Cancer

Cancer/tumors

Digestive System Neoplasms

Treatment

18F-DCFPyL

Clinical Study ID

NCT05095519
HREC/62461/PMCC
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 orwithout cirrhosis
  • Patients with liver lesions ≥1 cm suspicious for HCC but with indeterminate featureson CT and MRI meeting LI-RADS 3 or 4 criteria planned for biopsy, OR patients withliver lesions diagnostic of HCC based on CT or MRI meeting LI-RADS 5 criteria plannedfor surgical resection
  • Patients must be willing and able to comply with the protocol and procedures for theduration of the study
  • Patients must be available for follow-up

Exclusion

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 orcompliance
  • Any history of prostate cancer or elevated PSA level for male patients
  • Other malignancies unless curatively treated with no evidence of disease withinprevious 3-years other than adequately treated non-melanoma skin cancer or melanoma insitu
  • Participation in another clinical study with an investigational product or anothersystemic cancer therapy administered in the last 4 weeks
  • Has known psychiatric or substance abuse disorders that would interfere withcooperation with requirements of the study
  • Women who are pregnant or lactating
  • Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiarisyndrome) or cardiac cirrhosis

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: 18F-DCFPyL
Phase: 2
Study Start date:
September 08, 2021
Estimated Completion Date:
September 08, 2024

Study 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

Connect with a study center

  • St Vincent's Hospital

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • The Royal Melbourne Hospital

    Melbourne, Victoria
    Australia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.