Using Ga-PSMA PET/MRI to assess 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
Massachusetts General Hospital · NCT06265272
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 |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT06265272 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with liver cirrhosis based on imaging or clinical data.
Not a fit: Patients with contraindications to PET or MRI, or those who are pregnant or breastfeeding, may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charlestown, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cirrhosis, Hepatic Cell Carcinoma, Portal Hypertension, PET/MR, Cirrhosis, HCC, PSMA, 68Ga PSMA