Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
Recruiting now
Conditions studied: Liver Cirrhosis, Hepatic Cell Carcinoma, Portal Hypertension
In brief
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
Key facts
- Study ID
- NCT06265272
- Run by
- Massachusetts General Hospital
- People needed
- 45
- Starts
- 2023-12-10
- Expected to finish
- 2026-12-19
- Last updated by the study team
- 2025-09-26
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Liver cirrhosis as diagnosed by imaging and/or clinical data, including pathology
You may not qualify if…
- 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
Where it is running
- Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School — Charlestown, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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