PSCNot yet recruiting
PET/MRI of Primary Sclerosing Cholangitis
Observational · No treatment assigned · 1 site · Massachusetts General Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: PSC. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 99
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 17 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-12-10 (planned).
- Main results expected around 2029-04-30 (estimate from the record).
- 1 study site listed in United States.
Groups in this study
- PSC
Main thing being measured
- Diagnostic accuracy in detection of fibrotic components in patients with PSC ((1-2 Months))
- Quantification of fibrotic components in PSC (From date of PET/MRI examination to date of final histopathology result: (max. 1-2 Months))
In the researchers’ words
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…
Words you might see
- ULN: upper limit of normal: the top of the usual range for a lab test.
- Biopsy / histology: a small tissue sample examined under a microscope.
- Liver stiffness (elastography): a scan that estimates liver scarring.
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | PSC |
| Lead sponsor | Massachusetts General Hospital |
| Enrollment | 10 (estimated) |
| Start date | 2026-12-10 |
| Primary completion (est.) | 2029-04-30 |
| First posted | 2024-02-09 |
| Last updated | 2026-10-14 |
| Official title | PET/MRI Evaluation in Patients With Primary Sclerosing Cholangitis Using Intercellular Matrix Radiopharmaceuticals |
| ClinicalTrials.gov ID | NCT06252610 |
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 o… - 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 t… - 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, …
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School | Charlestown, Massachusetts | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.