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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

    Study type

    DIAGNOSTIC

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05095519

    Intervention or treatment

    DRUG: 18F-DCFPyL

    Conditions

    • Hepatocellular Carcinoma

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    True Positive Rate per patientThe 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 patientThe 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 lesionThe 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 MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    PSMA uptakeQualitative uptake of PSMA measured on a per lesion basis.6 months
    Maximum standard uptake valueMaximum standard uptake value of lesions on PSMA PET/CT.6 months
    CT LIRADS (Liver Imaging Reporting and Data System) ScoreLI RADS Score for CT lesions.6 months
    PSMA expression.Expression of PSMA per lesion.6 months
    GLUT-1 expressionExpression of GLUT 1 per lesion.6 months

    Frequently Asked Questions

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    References

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

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