PET/MRI of Primary Sclerosing Cholangitis

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06252610
Status
Not Yet Recruiting

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Conditions

  • PSC

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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 Dates

Start date
May 10, 2026
Status verified
Oct 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: PSC
    Population will be consecutive patients with PSC, who will be referred to us by the MGB-affiliated hepatologists.

Primary Outcome Measure

Diagnostic accuracy in detection of fibrotic components in patients with PSC [ Time Frame: (1-2 Months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical SchoolCharlestownMassachusetts02129-

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

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