RecruitingNCT06265272

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

Sponsor

Massachusetts General Hospital

Enrollment

45 participants

Start Date

Dec 10, 2023

Study Type

OBSERVATIONAL

Conditions

Liver Cirrhosis Portal Hypertension Hepatic Cell Carcinoma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a specialized PET/MRI scan (using a radiotracer called PSMA-11, normally used for prostate cancer imaging) can provide new insights into liver cirrhosis (scarring of the liver), potentially improving how it is diagnosed and monitored. **You may be eligible if...** - You have been diagnosed with liver cirrhosis, confirmed by imaging, clinical data, or biopsy **You may NOT be eligible if...** - You have a contraindication to PET or MRI scanning - You are allergic to gadolinium (the contrast dye used in MRI) - You are pregnant or breastfeeding - You weigh more than 300 lbs or have a BMI over 33 (due to scanner size limits) - You have had significant radiation exposure from research studies in the past 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInjection of a gadolinium contrast agen

All patients will be requested to have an injection of a gadolinium contrast agent, which may be either Gadavist (Bayer, Whippany, NJ, USA), Eovist (Bayer, Whippany, NJ, USA), or Dotarem (Guerbet, Princeton, NJ, USA) (ancillary drugs). * About halfway through the examination, the same intravenous catheter used to inject the radiotracer will be used to inject the MRI contrast agent; * After being positioned on the PET/MRI table, the nuclear medicine technicians will connect the patient to the MRI-safe power-injector; - The catheter will be flushed before and after injection with 0.9% saline solution;

DRUGRadiotracer Injection

All patients will be requested to have a radiotracer injection of Ga-PSMA (Illucix, Telix Pharmaceuticals). An intravenous catheter will be placed in an arm or hand vein for injection of the Ga-PSMA; * The catheter will be flushed post-injection with 0.9% saline solution * The injected dose and the time of injection will be recorded. * The subjects will be positioned on the scanner table; support devices under the back and/or legs will be used to enable the patient to comfortably maintain his/her position throughout the scan

DIAGNOSTIC_TESTImaging

PET, MRI and fused PET/MRI images will be qualitatively assessed in comparison to standard of reference data. For PET, standard of reference will be PET images as obtained by standard PET acquisition mode. Attenuation correction of the PET images will be performed using a 2-point Dixon MRI sequence and a vendor-specific atlas-based attenuation map. 3D scatter correction by single scatter simulation is also performed using the MRI-derived attenuation data. MRI images will be compared to dedicated 3 Tesla MR upper abdominal protocol images acquired at the MGH in patients with liver cirrhosis, including those undergoing imaging follow-up after systemic or local regional therapies. For PET/MRI fused images, the standard of reference will be co-registered and fused PET/MRI images as obtained by standard MRI sequences/reconstructions.