PET/MRI of Primary Sclerosing Cholangitis

NCT06252610 | Not Yet Recruiting FDA Drug

• 1 other identifier: 2022P002225
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PSC

Keywords

PSC; [18F]-FAPI-74; [68Ga]CBP8-PET; PET/MR; Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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.

  (1-2 Months)

• 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.

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

Secondary Outcomes (2)

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

  1-2 Months

• Correlation of PET parameters with MRI parameters

  1-2 Months

Study Arms (1)

PSC

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

Drug: Radiotracer Injection; Drug: Contrast Media, Magnetic Resonance; Diagnostic Test: Imaging

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.

PSC

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.

PSC

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

PSC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

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

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (14)

• Ludwig J. Surgical pathology of the syndrome of primary sclerosing cholangitis. Am J Surg Pathol. 1989;13 Suppl 1:43-9.

  PMID: 2699167 BACKGROUND

• Lindor KD, Kowdley KV, Harrison ME; American College of Gastroenterology. ACG Clinical Guideline: Primary Sclerosing Cholangitis. Am J Gastroenterol. 2015 May;110(5):646-59; quiz 660. doi: 10.1038/ajg.2015.112. Epub 2015 Apr 14.

  PMID: 25869391 BACKGROUND

• Dave M, Elmunzer BJ, Dwamena BA, Higgins PD. Primary sclerosing cholangitis: meta-analysis of diagnostic performance of MR cholangiopancreatography. Radiology. 2010 Aug;256(2):387-96. doi: 10.1148/radiol.10091953.

  PMID: 20656832 BACKGROUND

• Tafur M, Cheung A, Menezes RJ, Feld J, Janssen H, Hirschfield GM, Jhaveri KS. Risk stratification in primary sclerosing cholangitis: comparison of biliary stricture severity on MRCP versus liver stiffness by MR elastography and vibration-controlled transient elastography. Eur Radiol. 2020 Jul;30(7):3735-3747. doi: 10.1007/s00330-020-06728-6. Epub 2020 Mar 4.

  PMID: 32130494 BACKGROUND

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  PMID: 25451885 BACKGROUND

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  PMID: 31161770 BACKGROUND

• Catalano OA, Gee MS, Nicolai E, Selvaggi F, Pellino G, Cuocolo A, Luongo A, Catalano M, Rosen BR, Gervais D, Vangel MG, Soricelli A, Salvatore M. Evaluation of Quantitative PET/MR Enterography Biomarkers for Discrimination of Inflammatory Strictures from Fibrotic Strictures in Crohn Disease. Radiology. 2016 Mar;278(3):792-800. doi: 10.1148/radiol.2015150566. Epub 2015 Oct 5.

  PMID: 26436860 BACKGROUND

• Catalano OA, Wu V, Mahmood U, Signore A, Vangel M, Soricelli A, Salvatore M, Gervais D, Rosen BR. Diagnostic performance of PET/MR in the evaluation of active inflammation in Crohn disease. Am J Nucl Med Mol Imaging. 2018 Feb 5;8(1):62-69. eCollection 2018.

  PMID: 29531862 BACKGROUND

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  PMID: 24389304 BACKGROUND

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  PMID: 27723798 BACKGROUND

• Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A, Mier W, Adeberg S, Rathke H, Rohrich M, Winter H, Plinkert PK, Marme F, Lang M, Kauczor HU, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019 Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6.

  PMID: 30954939 BACKGROUND

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  PMID: 33127618 BACKGROUND

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  PMID: 32591493 BACKGROUND

• Sanchez-Crespo A. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission tomography. Appl Radiat Isot. 2013 Jun;76:55-62. doi: 10.1016/j.apradiso.2012.06.034. Epub 2012 Aug 29.

  PMID: 23063597 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Interventions

Contrast Media; Magnetic Resonance Spectroscopy; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Onofrio Catalano, MD, Ph.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Onofrio Catalano, MD, Ph.D

CONTACT

617-724-4030; ocatalano@mgh.harvard.edu

Diandrea Galloway

CONTACT

617-643-1407; dgalloway@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 9, 2024
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)