Clinical trial · Interventional
PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
Added Value of PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
NCT05580835CI-TRIAL-00061453unknownN/AClinicalTrials.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)
Assess the rate and degree of PSMA uptake in patients with hepatocellular carcinoma submitted to PET/MRI scans. The objective is to evaluate its value on diagnosis and staging of HCC.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET MRI with PSMA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET MRI - PSMA
- description
- Patients with an imaging diagnosis of HCC and submitted to PET MRI - PSMA
- interventionNames
- Diagnostic Test: PET MRI with PSMA
Primary outcomes (2)
- measure
- Diagnostic performance of PET MRI - PSMA for HCC
- timeFrame
- 24 months
- description
- Patients with a liver lesion diagnosed as hepatocellular carcinoma by MRI or CT and candidates to surgical resection or liver transplant will be submitted to PET MRI with PSMA. Based on the presence or absence of PSMA uptake, sensitivity and specificity of PET MRI for diagnosis of the liver lesion and extrahepatic disease will be calculated.
- measure
- Degree of PSMA uptake by HCC
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with an imaging diagnosis of HCC by a previous CT or MRI, reviewed by an abdominal radiologist * Patients candidates to liver transplant or surgical resection Exclusion Criteria: * Patients with treated liver lesion without viable tumor * Age under 18 * Pregnancy * Patients with renal insufficiency; * Elevated bilirubin levels (\>3 mg/dL) * Known allergy to contrast media (gadoxetic acid) or radiotracer (PSMA); * Blood glucose level higher than 150 mg/dl. * MR contraindications (claustrophobia, cardiac pacemakers, neurostimulators, cochlear implants, and insulin pumps).
References
Publications (0)
Data not yet available
No reference posted for this study.