Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
Recruiting · NCT06265272 · Observational (researchers observe without assigning treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School - Charlestown, Massachusetts, United States