NCT06265272 Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis
| NCT ID | NCT06265272 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Liver Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-12-10 |
| Primary Completion | 2026-12-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2023-12-10 with a primary completion date of 2026-12-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Onofrio Catalano
PRINCIPAL INVESTIGATOR
ocatalano@mgh.harvard.edu
Frequently Asked Questions
Who can join the NCT06265272 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06265272 currently recruiting?
Yes, NCT06265272 is actively recruiting participants. Contact the research team at ocatalano@mgh.harvard.edu for enrollment information.
Where is the NCT06265272 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT06265272 clinical trial?
NCT06265272 is sponsored by Massachusetts General Hospital. The principal investigator is Onofrio Catalano at ocatalano@mgh.harvard.edu. The trial plans to enroll 45 participants.