Clinical trial NCT05095519: Hepatocellular Carcinoma Imaging Using PSMA PET/CT
Official title: Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
PSMA
18F-DCFPyL
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

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

Eligibility criteria: 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

Primary outcomes:
measure: True Positive Rate per patient
timeFrame: 6 months
measure: True Negative Rate per patient
timeFrame: 6 months
measure: True Positive Rate per lesion
timeFrame: 6 months
measure: True Negative Rate per lesion.
timeFrame: 6 months
Secondary outcomes:
measure: PSMA uptake
timeFrame: 6 months
measure: Maximum standard uptake value
timeFrame: 6 months
measure: CT LIRADS (Liver Imaging Reporting and Data System) Score
timeFrame: 6 months
measure: PSMA expression.
timeFrame: 6 months
measure: GLUT-1 expression
timeFrame: 6 months
Other outcomes:
Locations:
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
References: