Back to search results

Understanding Liver Cirrhosis with Ga-PSMA-11 PET/MRI

This study is looking at how well a special imaging technique, called Ga-PSMA-11 PET/MRI, can assess liver cirrhosis (scarring of the liver). Researchers want to see if this imaging can help understand changes in the liver, including blood flow and how well the liver is working. You would receive an injection of a gadolinium contrast agent (like Gadavist, Eovist, or Dotarem) and a radiotracer called Ga-PSMA-11 (Illucix) before having PET and MRI scans. The study aims to enroll 45 people aged 18 to 99 who have been diagnosed with liver cirrhosis. The main goal is to see how well Ga-PSMA-PET/MRI can help classify liver conditions.

Study design
This is an observational study, meaning researchers will observe and collect information without assigning specific treatments. It plans to enroll 45 participants.
What's involved
You would receive injections of a gadolinium contrast agent and Ga-PSMA-11, followed by PET and MRI scans. An intravenous catheter will be placed for the Ga-PSMA-11 injection.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, assessment of LI-RADS, is measured at 1-2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06265272

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

Recruiting
Not specifiedAges 18–99Observational
Massachusetts General Hospital
~45 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:Injection of a gadolinium contrast agenRadiotracer InjectionImaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of LI-RADS with Ga-PSMA-PET/MRI
Measured over 1-2 Months

Conditions

Liver Cirrhosis
Hepatic Cell Carcinoma
Portal Hypertension

Explore related trials

CirrhosisHepatocellular CarcinomaPortal Hypertension

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

Who to contact

Onofrio Catalano, MD, Ph.D
[email protected]
617-724-4030
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Liver cirrhosis as diagnosed by imaging and/or clinical data, including pathology

Exclusion

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

What this trial measures

  • Assessment of LI-RADS with Ga-PSMA-PET/MRI1-2 Months

    PET, MRI, and fused PET/MRI images will be evaluated to determine the effect of contrast-enhanced Ga-PSMA/PETMRI on evaluating liver nodules. Images will be evaluated at least 4 weeks apart from each other to reduce recall bias. Each lesion described by the readers of the imaging modalities will then be classified accordingly into true positive, false positive, true negative, or false negative. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will then be computed using adequate proportions as estimates.