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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
Who can join
Ages 18 to 99 · All sexes
Full eligibility criteria
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
About the study
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
What is being tested
- Injection of a gadolinium contrast agen (drug)
- Radiotracer Injection (drug)
- Imaging (diagnostic test)
Sponsor: Massachusetts General Hospital · Participants: 45 · Started: Dec 10, 2023
Contact the study team
- Onofrio Catalano, MD, Ph.D · Phone: 617-724-4030
- Diandrea Galloway · Phone: 617-643-1407
Official record on ClinicalTrials.gov — NCT06265272
Locations in the U.S.
| Massachusetts | Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.