Clinical trial · Interventional
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial
NCT05095519CI-TRIAL-00122511HepaSMARTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DCFPyL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL
- description
- Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL
- interventionNames
- Drug: 18F-DCFPyL
Primary outcomes (4)
- measure
- True Positive Rate per patient
- timeFrame
- 6 months
- description
- The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.
- measure
- True Negative Rate per patient
- timeFrame
- 6 months
- description
- The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.