Clinical trial · Observational
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
Technical Development and Clinical Validation of a Comprehensive One-stop Shop Assessment of the Cirrhotic Liver With [68Ga]Ga-PSMA-11 PET/MRI
- 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)
A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols. The specific hypotheses include: * Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients * Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation. * Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments * Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Cell Carcinoma | — | UNRESOLVED | — |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Portal Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging | Diagnostic Test | — | UNRESOLVED |
| Injection of a gadolinium contrast agen | Drug | — | UNRESOLVED |
| Radiotracer Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cirrhosis
- description
- 55 Patients with liver cirrhosis
- interventionNames
- Drug: Injection of a gadolinium contrast agen
- Drug: Radiotracer Injection
- Diagnostic Test: Imaging
Primary outcomes (1)
- measure
- Assessment of LI-RADS with Ga-PSMA-PET/MRI
- timeFrame
- 1-2 Months
- description
- PET, MRI, and fused PET/MRI images will be evaluated to determine the effect of contrast-enhanced Ga-PSMA/PETMRI on evaluating liver nodules. Images will be evaluated at least 4 weeks apart from each other to reduce recall bias. Each lesion described by the readers of the imaging modalities will then be classified accordingly into true positive, false positive, true negative, or false negative. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will then be computed using adequate proportions as estimates.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Liver cirrhosis as diagnosed by imaging and/or clinical data, including pathology Exclusion Criteria: * Any contraindication to PET, as in attached screening form * Any contraindication to MRI, as in attached screening form * Any contraindication to gadolinium-based contrast agent, including allergy to gadolinium, as in attached screening forms. * Pregnancy * Breast feeding. * Cumulative radiation exposure for research studies during the prior 12 months, combined with the exposure from this study, \> 50 mSv * Inability to fit in the scanner: weight \> 300 lbs or BMI \> 33
References
Publications (37)
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- BACKGROUNDChoi JW, Chung JW, Lee DH, Kim HC, Hur S, Lee M, Jae HJ. Portal hypertension is associated with poor outcome of transarterial chemoembolization in patients with hepatocellular carcinoma. Eur Radiol. 2018 May;28(5):2184-2193. doi: 10.1007/s00330-017-5145-9. Epub 2017 Dec 7. PMID 29218611
- BACKGROUNDLee KH, Sung KB, Lee DY, Park SJ, Kim KW, Yu JS. Transcatheter arterial chemoembolization for hepatocellular carcinoma: anatomic and hemodynamic considerations in the hepatic artery and portal vein. Radiographics. 2002 Sep-Oct;22(5):1077-91. doi: 10.1148/radiographics.22.5.g02se191077. PMID 12235337
- BACKGROUNDChen X, Xiao E, Shu D, Yang C, Liang B, He Z, Bian D. Evaluating the therapeutic effect of hepatocellular carcinoma treated with transcatheter arterial chemoembolization by magnetic resonance perfusion imaging. Eur J Gastroenterol Hepatol. 2014 Jan;26(1):109-13. doi: 10.1097/MEG.0b013e328363716e.