Clinical trial · Interventional
Clinical Application of 68Ga-PSMA PET/MR for Diagnosis and Staging in Hepatocellular Carcinoma
A Prospective Study of Clinical Application of 68Ga-PSMA PET/MR for Diagnosis and Staging in Hepatocellular Carcinoma
NCT05006326CI-TRIAL-00063911unknownN/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)
In this prospective study, 68Ga-PSMA integrated PET/MR imaging was applied for the diagnosis and staging of hepatocellular carcinoma (HCC). The detection and diagnostic performance of 68Ga-PSMA PET/MR for HCC was evaluated in comparison with the gold standard of puncture biopsy or postoperative pathology. The aim is to make up for the deficiency in FDG PET imaging in the 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 |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA | Drug | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
| PET/MR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA PET/MR
- description
- The investigators selected patients with a high clinical suspicion of HCC, or patients with confirmed HCC without tumour-related treatment who were to be biopsied or surgically resected to obtain pathological results. Patients signed an informed consent form and underwent 68Ga-PSMA PET/MR imaging (or PET/CT imaging if the patient had a contraindication to MR imaging).
- interventionNames
- Drug: 68Ga-PSMA
- Device: PET/MR
- Device: PET/CT
Primary outcomes (1)
- measure
- Sensitivity and specificity of 68Ga-PSMA PET/MR for diagnosis and staging in hepatocellular carcinoma.
- timeFrame
- 1 year
- description
- For patients without any treatment, the initial diagnosis and staging results of 68Ga-PSMA PET/MR (PET/CT) will be compared with pathological, clinical and follow-up results.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Each subject must meet all the inclusion criteria to be eligible for the study. * Subjects or their legal representatives are able to sign an informed consent form * Subjects are committed to comply with the study procedures and cooperate with the implementation of the full study * Subjects are 18 years of age or older, regardless of gender * Subjects with high suspicion of HCC, or diagnosed HCC without tumour-related treatment (supporting evidence including serum AFP, MRI, CT and other imaging data and histopathology), and in good general condition * Subjects intend to obtain pathological results by biopsy or surgical resection Exclusion Criteria: All patients meeting any of the exclusion criteria will be excluded from the study. * Patients or their legal representatives are unable or unwilling to sign the informed consent form * Patients are unable to cooperate in the conduct of the full study * Patients with acute systemic illness and electrolyte disturbances * Patients with other previous malignancies or a combination of other malignancies * Patients who are pregnant or lactating women
References
Publications (1)
- DERIVEDQin C, Song X, Sun S, Song Y, Ruan W, Gai Y, Yang M, Wan C, Lan X. [68Ga]Ga-PSMA-617 PET/MRI for imaging patients suspected of hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1278-1290. doi: 10.1007/s00259-024-06973-7. Epub 2024 Nov 21. PMID 39570398