Using PSMA PET/CT for imaging liver cancer

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

This study is testing if a new type of scan called PSMA PET/CT can better diagnose liver cancer in people who have either confirmed liver cancer or unclear liver spots that need more checking.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peter MacCallum Cancer Centre, Australia (Academic / other)
• Locations: 4 sites (Fitzroy, Victoria and 3 other locations)
• Trial ID: NCT05095519 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of PSMA PET/CT scans in diagnosing hepatocellular carcinoma (HCC) compared to standard imaging techniques like CT and MRI. It will recruit 30 patients who either have confirmed HCC or indeterminate liver lesions that require further investigation. Participants will undergo the 18F-DCFPyL PSMA PET/CT scan before their scheduled surgery or biopsy. The goal is to determine if this new imaging method can provide better diagnostic accuracy for HCC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with risk factors for HCC and specific liver lesions that meet certain imaging criteria.

Not a fit: Patients with a history of prostate cancer or those who have had recent abdominal surgery or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses of liver cancer, improving treatment planning and patient outcomes.

How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, indicating potential for success.

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

Where this trial is running

Fitzroy, Victoria and 3 other locations

• St Vincent's Hospital — Fitzroy, Victoria, Australia (Recruiting)
• Austin Health — Heidelberg, Victoria, Australia (Recruiting)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
• The Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Grace Kong

Conditions Hepatocellular Carcinoma; Hepatocellular carcinoma; PSMA; 18F-DCFPyL