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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "PET/MRI images will be acquired using the Biograph mMR combined 3 Tesla PET/MRI scanner."
  • "PSMA-PET/MRI quantitative and qualitative features, including hybrid biomarkers obtained incorporating PSMA uptake with MRp and/or 4D-MRI and/or DWI extracted parameters, with clinical data that provide insights into liver function and liver hemodynamics 3."
  • "PSMA-PET/MRI qualitative and quantitative features (for example vascular permeability or median velocity), including hybrid biomarkers, with clinical data to explore possibility of assessing liver function, quantify fibrosis, facilitate Li-Rad classification, measure hemodynamics in cirrhotic patients including those treated/ to be treated for portal hypertension. 4."
  • "Comparison of fused Ga-PSMA PET/MRI images with stand-alone MRI images and stand-alone PET images obtained in the same scan in terms of qualitative and quantitative imaging features, for example confidence in characterization of band-like fibrosis or differentiation of mild from moderate degree of fibrosis. 5."
  • "The investigators will also follow up patients to ascertain if Ga-PSMA PET/MRI result might have impacted on clinical management."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a combined PET/MRI scan called Ga-PSMA PET/MRI in 55 people with liver cirrhosis, or liver scarring. Researchers will study whether the scan can measure liver blood flow, scarring, and function, and help predict how cirrhosis changes over time.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have liver cirrhosis confirmed by scans, medical findings, or tests of liver tissue.

Who can't join

  • You have a condition that makes a PET scan unsafe, as listed on the study’s screening form.
  • You have a condition that makes an MRI scan unsafe, as listed on the study’s screening form.
  • You cannot safely receive gadolinium, a dye used for scans, including because of an allergy.
  • You are pregnant.
  • You are breastfeeding.
  • Your radiation from research studies in the past 12 months, plus this study, would be more than 50 mSv, a unit of radiation exposure.
  • You cannot fit in the scanner: you weigh more than 300 pounds or have a body mass index (BMI) over 33. BMI is a measure based on height and weight.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA