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PET/MRI of Primary Sclerosing Cholangitis

ConditionPSC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

In total, 10 subjects with PSC fulfilling the inclusion criteria will be recruited. All subjects recruited for the study will be able to withdraw from the study at any time. The patients will be referred to the study by their treating physicians to investigate liver or biliary tract fibrosis in the setting of PSC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiotracer Injection

    Drug

    An intravenous catheter will be placed in an arm or hand vein for injection of \[68Ga\]CBP8; * 6-10 mCi of \[68Ga\]CBP8 or 5-9 mCi of FAPI will be injected into the Biograph mMR system. The injected dose and the time of injection will be recorded; * The catheter will be flushed with 0.9% saline solution; * The subjects will then be positioned on the scanner table; support devices under the back or legs will be used to enable the patient to maintain his/her position throughout the scan comfortably.

  • Contrast Media, Magnetic Resonance

    Drug

    The same intravenous catheter used to inject the radiotracer will be used to inject the hepatospecific gadolinium contrast agent Eovist (Bayer, Whippany, NJ); * After being positioned on the PET/MRI table, the nuclear medicine technologist will connect the patient to the MRI-safe power injector; * The catheter will be flushed before and after injection with 0.9% saline solution; * About halfway through the imaging session, the study staff will inform the patient that they are going to be administering the contrast agent and what sensations they should and should not expect; * The contrast will then be injected.

  • Imaging

    Diagnostic test

    MRI and PET scanner to be used: 3.0 T Laboratory (Bay 7) Siemens Biograph mMR. Magnetic resonance images of the abdomen will be acquired using the Martinos Center's combined 3 Tesla PET/MRI scanner. The image quality on these 3 Tesla devices will be very high, equivalent to or better than any other standard clinical MRI system. PET images of the target body site will be acquired When necessary, the data acquisition will be started shortly before radiotracer injection; Coincidence event data will be acquired and stored in list mode or compressed (i.e., sinogram space) format. Subjects will be asked to lie still for the duration of the study. The entire imaging session will last up to 120 minutes

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: PSC3 interventions

Trial outcomes

Primary outcomes

1

Diagnostic accuracy in detection of fibrotic components in patients with PSC

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.

Time frame
(1-2 Months)
2

Quantification of fibrotic components in PSC

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.

Time frame
From date of PET/MRI examination to date of final histopathology result: (max. 1-2 Months)

Secondary outcomes

1

Correlation of PET parameters with clinical and imaging biomarkers/tests for fibrosis

Compare fibrosis levels as measured by \[68Ga\]CBP8 or \[18F\]FAPI-74-PET/MRI to selected fibrosis plasma biomarkers, fibroscan, and derived scores.

Time frame
1-2 Months
2

Correlation of PET parameters with MRI parameters

Compare fibrosis levels with gadoxetate contrast-enhanced and other MRI parameters (e.g., MRCP)

Time frame
1-2 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

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