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Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
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
Conditions:
🦠 Liver Cirrhosis 🦠 Hepatic Cell Carcinoma 🦠 Portal Hypertension
🗓️ Study Start (Actual) 10 December 2023
🗓️ Primary Completion (Estimated) 19 December 2026
✅ Study Completion (Estimated) 19 December 2026
👥 Enrollment (Estimated) 45
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Charlestown, Massachusetts, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2024
  • First Submitted that Met QC Criteria 9 February 2024
  • First Posted 20 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024
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