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Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis

RECRUITINGSponsored by Massachusetts General Hospital
Actively Recruiting
SponsorMassachusetts General Hospital
Started2023-12-10
Est. completion2026-12-19
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06265272

Summary

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

Eligibility

Age: 18 Years – 99 YearsHealthy volunteers accepted
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

Conditions6

CancerHepatic Cell CarcinomaLiver CancerLiver CirrhosisLiver DiseasePortal Hypertension

Interventions2

Injection of a gadolinium contrast agenRadiotracer Injection

Locations1 site

Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Charlestown, Massachusetts, 02129
Onforio Catalano, MD, Ph.D617-724-4030ocatalano@mgh.harvard.edu

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