PET/MRI of Primary Sclerosing Cholangitis

Starting soon

Conditions studied: PSC

In brief

This study aims to use positron emission tomography (PET)/magnetic resonance imaging (MRI) to diagnose and quantify PSC-related biliary tract fibrosis and to improve upon the currently available non-invasive diagnostic capabilities by investigating the ability of combined PET/MRI to detect and quantify fibrosis using a novel collagen-binding radiotracer. Specifically, the investigators will be comparing \[68Ga\]CBP8- and \[18F\]-FAPI-74 PET/MRI to a liver transient elastography scan in the diagnosis of biliary tree fibrosis.

Key facts

Study ID

NCT06252610

Run by

Massachusetts General Hospital

People needed

10

Starts

2026-08-10

Expected to finish

2029-04-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Established clinical diagnosis of large duct PSC
• Participants receiving treatment for IBD are allowed if on a stable dose from screening and expected to remain stable for the duration of the study
• Serum AST and ALT concentration ≤ 8 times the upper limit of normal

You may not qualify if…

• Other causes of chronic liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
• Known or suspected overlapping clinical or histologic diagnosis of autoimmune hepatitis
• Subjects less than 18 years of age or greater than 85 years of age.
• Subjects with electrical implants, such as cardiac pacemakers or perfusion pumps.
• Subjects with ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing.
• Subjects who anticipate being pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate).
• Subjects with claustrophobic reactions
• Subjects with more significant than average potential for cardiac arrest.
• Subjects with a history of major head trauma (i.e., multiple concussions, traumatic brain injury).
• Subjects with a history of bleeding disorders.
• Subjects whose research-related radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months).
• Subjects unable to lie comfortably on a bed inside the PET/MRI bore as assessed by physical examination and medical history (e.g., back pain, arthritis).
• Subjects under the direct supervision of the principal investigator;
• Subjects with a body weight of > 300 lbs (operational weight limit of the PET/MRI table) or BMI >33 kg/m2 (the Athinoula A. Martinos Center standard procedure to avoid claustrophobia or mechanical impossibility of fitting the subject into the scanner bore, which is less than 60 cm wide).
• A history of acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2
• Perioperative liver transplantation period.
• A history of systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, or other comorbidities resulting in chronic kidney disease stage IV or higher

Where it is running

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

Full record on ClinicalTrials.gov

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