New scan may spot liver scarring without needle biopsy
NCT ID NCT06252610
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This study tests whether a combined PET/MRI scan can detect and measure liver scarring (fibrosis) in people with primary sclerosing cholangitis (PSC). Ten participants will receive two experimental tracers that bind to scar tissue, and results will be compared to standard tests like FibroScan. The goal is to improve non-invasive diagnosis and avoid the need for liver biopsies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Charlestown, Massachusetts, 02129, United States
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Other studies related to the condition(s) this trial covers.
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