Using Ga-PSMA PET/MRI to assess liver cirrhosis
Official title: Technical Development and Clinical Validation of a Comprehensive One-stop Shop Assessment of the Cirrhotic Liver With [68Ga]Ga-PSMA-11 PET/MRI
Run by Massachusetts General Hospital · NCT06265272 · Data updated 2026-11-12
This study is testing a new imaging method to see if it can help doctors better understand liver function and damage in people with liver cirrhosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Charlestown, Massachusetts) |
| Status | Recruiting |
| Started | December 10, 2023 |
| Main results expected | December 19, 2028 |
| Study ends | December 19, 2028 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT06265272 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with liver cirrhosis based on imaging or clinical data.
✕Probably not a fit
Patients with contraindications to PET or MRI, or those who are pregnant or breastfeeding, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll 55 patients with liver cirrhosis to validate specialized Ga-PSMA-PET/MRI protocols. The study aims to explore the ability of Ga-PSMA PET/MRI to noninvasively quantify liver hemodynamics, assess liver fibrosis, and evaluate portal venous hypertension. By utilizing advanced imaging techniques, the study seeks to improve the understanding of liver function and structure in cirrhotic patients, potentially enhancing treatment response predictions. The study will involve the injection of a gadolinium contrast agent and radiotracer, followed by imaging procedures.
Why it matters
Potential benefit: If successful, this study could provide a noninvasive method for better assessing liver cirrhosis and its complications, leading to improved patient management.
How similar studies have gone: While Ga-PSMA is primarily used for prostate cancer, its application in liver cirrhosis is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Charlestown, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Onofrio Catalano — ocatalano@mgh.harvard.edu
- Study coordinator: Onofrio Catalano, MD, Ph.D
- Email: ocatalano@mgh.harvard.edu
- Phone: 617-724-4030
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.