Liver Cirrhosis Clinical Trial
Official title:
Technical Development and Clinical Validation of a Comprehensive One-stop Shop Assessment of the Cirrhotic Liver With [68Ga]Ga-PSMA-11 PET/MRI
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
Status | Recruiting |
Enrollment | 45 |
Est. completion date | December 19, 2026 |
Est. primary completion date | December 19, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School | Charlestown | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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* Note: There are 37 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1-2 Months | |
Secondary | 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. | 1-2 months | |
Secondary | 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. | 1-2 months | |
Secondary | PET/MR protocol in liver cirrhosis | Develop PET/MRI acquisition protocols specific to liver cirrhosis | 12 months |
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