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Recruiting
NCT06265272
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
Conditions: Liver Cirrhosis, Hepatic Cell Carcinoma, Portal Hypertension
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 45
Sponsor: Massachusetts General Hospital
Location: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School Charlestown Massachusetts
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 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
Source: ClinicalTrials.gov (NCT06265272). StuddyBuddy aggregates publicly available trial information.
