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PET/MRI for Primary Sclerosing Cholangitis (PSC)

This study is looking at a new way to diagnose and measure liver scarring (fibrosis) in people with Primary Sclerosing Cholangitis (PSC). It uses a special type of scan called PET/MRI with two different injected substances: [68Ga]CBP8 or FAPI. These substances help highlight the scarring in your liver. Researchers want to see if this PET/MRI method is better than current tests at finding and measuring fibrosis. You might be able to join if you have a confirmed diagnosis of PSC, are between 18 and 99 years old, and meet certain liver enzyme levels. The study aims to see how accurately this new scan can detect and measure fibrosis within one to two months.

Study design
This is an observational study with a planned enrollment of 10 participants. It is not a randomized or blinded study.
What's involved
You would receive injections of a radiotracer ([68Ga]CBP8 or FAPI) and a contrast agent (Eovist) through an IV, followed by a PET/MRI scan of your abdomen.
Compensation
Not stated in the trial record.
Follow-up
The study will measure diagnostic accuracy within 1-2 months and quantify fibrosis from the date of the PET/MRI examination to the date of the final histopathology result (maximum 1-2 months).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06252610

PET/MRI of Primary Sclerosing Cholangitis

Not Yet Recruiting
Not specifiedAges 18–99Observational
Massachusetts General Hospital
~10 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Radiotracer InjectionContrast Media, Magnetic ResonanceImaging

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic accuracy in detection of fibrotic components in patients with PSC
Measured over (1-2 Months)
+1 more outcome measured

Conditions

PSC

Explore related trials

Primary Sclerosing Cholangitis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Onofrio Catalano, MD, Ph.D · PRINCIPAL_INVESTIGATOR · Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

Who to contact

Onofrio Catalano, MD, Ph.D
[email protected]
617-724-4030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Diagnostic accuracy in detection of fibrotic components in patients with PSC(1-2 Months)

    To establish the diagnostic capabilities (sensitivity, specificity, accuracy) of PET/MRI using \[68Ga\]CBP8 or \[18F\]-FAPI-74 for detection of the fibrotic component in patients with PSC.

  • Quantification of fibrotic components in PSCFrom date of PET/MRI examination to date of final histopathology result: (max. 1-2 Months)

    Quantification of fibrotic component in patients with PSC with \[68Ga\]CBP8- or \[18F\]-FAPI-74-PET/MT by using liver histology (when available) as the standard for comparison. If histology is unavailable, non-invasive tests (FibroScan, MRI Elastography, serum biomarkers) will be used.