PET/MRI of Primary Sclerosing Cholangitis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose a liver condition called primary sclerosing cholangitis (PSC). PSC can cause damage to the bile ducts, which can lead to serious health issues. The researchers want to see if a special imaging technique called PET/MRI, which combines two types of scans, can better detect and measure the amount of damage to the bile ducts compared to the standard tests currently used. They will use a special tracer that highlights the areas affected by PSC during the scan.

To participate in this study, you must be between 18 and 85 years old and have a confirmed diagnosis of large duct PSC. If you're currently being treated for inflammatory bowel disease (IBD), that’s okay as long as your treatment is stable. However, some people cannot join, including those with certain other liver diseases, serious health issues, or those with specific medical implants. If you qualify, you can expect to undergo a PET/MRI scan, which will help researchers learn more about PSC and improve future diagnosis and treatment options. Please note that the study is not yet recruiting participants, so keep an eye out for updates if you're interested.

Gender

ALL

Eligibility criteria

• 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