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

NCT06265272 | Recruiting

• 1 other identifier: 2022P002594
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Cirrhosis; Hepatic Cell Carcinoma; Portal Hypertension

Keywords

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

Outcome Measures

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.

  1-2 Months

Secondary Outcomes (3)

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

  1-2 months

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

  1-2 months

• PET/MR protocol in liver cirrhosis

  12 months

Study Arms (1)

Cirrhosis

55 Patients with liver cirrhosis

Drug: Injection of a gadolinium contrast agen; Drug: Radiotracer Injection; Diagnostic Test: Imaging

Interventions

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;

Cirrhosis

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

Cirrhosis

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.

Cirrhosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

Charlestown, Massachusetts, 02129, United States

RECRUITING

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Related Links

• Center for Drug Evaluation, Research. FDA approves PSMA-targeted imaging drug for men with prostate cancer. U.S. Food and Drug Administration. Published September 30, 2021. Accessed April 11, 2022.
• Telix Pharmaceuticals. Illucix Full Prescribing Information. Published December 2021. Accessed September 21, 2022.

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Hypertension, Portal; Fibrosis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Onofrio Catalano

  ocatalano@mgh.harvard.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Onofrio Catalano, MD, Ph.D

CONTACT

617-724-4030; ocatalano@mgh.harvard.edu

Diandrea Galloway

CONTACT

617-643-1407; dgalloway@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Harvard Medical School, PET/MR Translation Officer, Medical Director PET/MR at the Athinoula A. Martinos Center for Biomedical Imaging

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: December 10, 2023
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)