Recruiting

[68Ga]Ga-PSMA-11

Sponsor:

Massachusetts General Hospital

Code:

NCT06265272

Conditions

Liver Cirrhosis

Hepatic Cell Carcinoma

Portal Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Injection of a gadolinium contrast agen

Radiotracer Injection

Imaging

Study Details

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

Study ID

NCT06265272

Start date

Dec 10, 2023

Status verified date

Sep, 2025

Completion date

Dec 19, 2026

Anticipated

Primary completion date

Dec 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Cirrhosis

55 Patients with liver cirrhosis

Interventions

Injection of a gadolinium contrast agen

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;

Radiotracer Injection

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

Imaging

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.

Primary outcome measure

  • Assessment of LI-RADS with Ga-PSMA-PET/MRI [ Time Frame: 1-2 Months ]

Central Contacts and Locations

Central contacts

Onofrio Catalano, MD, Ph.D

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

Diandrea Galloway

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

Locations

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

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Onforio Catalano, MD, Ph.D

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

Diandrea Galloway

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

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-26.