RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-12-10
Study Completion:2026-12-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06265272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Liver cirrhosis as diagnosed by imaging and/or clinical data, including pathology
  1. * Any contraindication to PET, as in attached screening form
  2. * Any contraindication to MRI, as in attached screening form
  3. * Any contraindication to gadolinium-based contrast agent, including allergy to gadolinium, as in attached screening forms.
  4. * Pregnancy
  5. * Breast feeding.
  6. * Cumulative radiation exposure for research studies during the prior 12 months, combined with the exposure from this study, \> 50 mSv
  7. * Inability to fit in the scanner: weight \> 300 lbs or BMI \> 33

Contacts and Locations

Study Contact

Onofrio Catalano, MD, Ph.D
CONTACT
617-724-4030
ocatalano@mgh.harvard.edu
Diandrea Galloway
CONTACT
617-643-1407
dgalloway@mgh.harvard.edu

Principal Investigator

Onofrio Catalano
PRINCIPAL_INVESTIGATOR
ocatalano@mgh.harvard.edu

Study Locations (Sites)

Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Charlestown, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Onofrio Catalano, PRINCIPAL_INVESTIGATOR, ocatalano@mgh.harvard.edu

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-10
Study Completion Date2026-12-19

Study Record Updates

Study Start Date2023-12-10
Study Completion Date2026-12-19

Terms related to this study

Keywords Provided by Researchers

  • PET/MR
  • Cirrhosis
  • HCC
  • PSMA
  • 68Ga PSMA

Additional Relevant MeSH Terms

  • Liver Cirrhosis
  • Hepatic Cell Carcinoma
  • Portal Hypertension