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Cirrhosis for Liver Cirrhosis

N/A
Recruiting
Led By Onofrio Catalano
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Liver cirrhosis as diagnosed by imaging and/or clinical data, including pathology
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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

Eligible Conditions
  • Liver Cirrhosis
  • Liver Cancer
  • Portal Hypertension

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of LI-RADS with Ga-PSMA-PET/MRI
Secondary outcome measures
PET/MR protocol in liver cirrhosis
Quantification of Macro- and Microperfusion in Cirrhotic Liver with Ga-PSMA-PET/MRI
Quantification of liver fibrosis with Ga-PSMA-PET/MRI vs. MRI and stand-alone PET

Trial Design

1Treatment groups
Experimental Treatment
Group I: CirrhosisExperimental Treatment3 Interventions
55 Patients with liver cirrhosis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imaging
2016
Completed Phase 3
~134060

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,929 Previous Clinical Trials
13,198,260 Total Patients Enrolled
8 Trials studying Liver Cirrhosis
625 Patients Enrolled for Liver Cirrhosis
Onofrio CatalanoPrincipal Investigatorocatalano@mgh.harvard.edu

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Magnetic Resonance ImagingJournal
Diagnostic Performance of CT, Gadoxetate Disodium-enhanced MRI, and PET/CT for the Diagnosis of Colorectal Liver Metastasis: Systematic Review and Meta-analysis
Choi, Sang Hyun, So Yeon Kim, Seong Ho Park, Kyung Won Kim, Ja Youn Lee, Seung Soo Lee, and Moon-Gyu Lee. 2017. “Diagnostic Performance of CT, Gadoxetate Disodium-enhanced MRI, and PET/CT for the Diagnosis of Colorectal Liver Metastasis: Systematic Review and Meta-analysis”. Journal of Magnetic Resonance Imaging. Wiley. doi:10.1002/jmri.25852.
clinicaltrials.govStudy
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
Onofrio A. Catalano, MD, PhD 2023. "Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06265272.
All > Paid Studies Boston
~30 spots leftby Dec 2026
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