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

ConditionsLiver CirrhosisHepatic Cell CarcinomaPortal Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMassachusetts General Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Fifty-five subjects will be recruited. All subjects recruited for the study will be able to withdraw from the study at any time. Healthy Volunteers: The investigators will not be recruiting or enrolling healthy volunteers in this study. Patients with liver cirrhosis: Fifty-five (55)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Injection of a gadolinium contrast agen

    Drug

    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;

  • Radiotracer Injection

    Drug

    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

  • Imaging

    Diagnostic test

    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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Cirrhosis3 interventions

Trial outcomes

Primary outcomes

1

Assessment of LI-RADS with Ga-PSMA-PET/MRI

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.

Time frame
1-2 Months

Secondary outcomes

1

Quantification of Macro- and Microperfusion in Cirrhotic Liver with Ga-PSMA-PET/MRI

Investigators will correlate PSMA-PET/MRI quantitative and qualitative features (for example vascular permeability or median velocity), 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.

Time frame
1-2 months
2

Quantification of liver fibrosis with Ga-PSMA-PET/MRI vs. MRI and stand-alone PET

Investigators will perform a 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 to measure the amount of band-like fibrosis and differentiate between mild and moderate degrees of fibrosis.

Time frame
1-2 months
3

PET/MR protocol in liver cirrhosis

Develop PET/MRI acquisition protocols specific to liver cirrhosis

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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