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PSCNCT06252610

PET/MRI of Primary Sclerosing Cholangitis

An observational study of PSC, run by Massachusetts General Hospital at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
PSC
What is being tested?
Radiotracer Injection, Contrast Media, Magnetic Resonance and Imaging
Type of treatment
Injection or infusion
How many people
10 participants
Where
1 siteUnited States
Study dates
10 Dec 2026to 30 Apr 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Onofrio Catalano, MD, Ph.D contact

617-724-4030

ocatalano@mgh.harvard.edu

Diandrea Galloway contact

617-643-1407

dgalloway@mgh.harvard.edu

United States1 site

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

    Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Official title: PET/MRI Evaluation in Patients With Primary Sclerosing Cholangitis Using Intercellular Matrix Radiopharmaceuticals

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.

Read the detailed description

Imaging in the form of cholangiography plays an essential role in diagnosing and managing PSC. In the past decade, magnetic resonance cholangiopancreatography (MRCP) has become preferred over endoscopic retrograde cholangiopancreatography (ERCP) for the diagnosis of PSC because it is non-invasive, thereby safer, and cheaper than ERCP. MRCP's sensitivity and specificity for diagnosing PSC are high, 86% and 94%, respectively. However, to quantify liver fibrosis, MRCP is only accurate in more advanced stages of the disease. Intrahepatic biliary stricture severity was a poor discriminator between the different grades of liver fibrosis measured on magnetic resonance elastography and the different risk strata according to the Mayo Risk Score and The Amsterdam-Oxford prognostic index (AOPI). Other non-invasive diagnostic tests, such as transient elastography, lack full-organ evaluation and may be subject to variation between measurements, despite being the current gold standard for non-invasive fibrosis quantification.

This study aims to use [68Ga]CBP8- or [18F]FAPI PET/MRI to diagnose and quantify PSC-related biliary tract fibrosis. The novel radiopharmaceutical collagen-binding probe 8 labeled with Gallium-68 selectively binds to collagen type I, the predominant extracellular protein in fibrosis. [68Ga]CBP8 has already been investigated in patients affected by pulmonary fibrosis with success. Fibroblast activation protein (FAP) is a type II transmembrane serine protease that is overexpressed in CAFs and, to a lesser extent, in benign processes. It is associated with extracellular matrix remodeling, for example, chronic inflammation, degenerative bone and spine disease, arthritis, and cardiac remodelling after myocardial infarction. Quinolone-based FAP inhibitors (FAPIs) constitute a class of molecules with high affinity to FAP deployed to assess many types of solid tumors and some benign pathologies. 68Ga-FAPIs and, to a lesser extent, 18F-FAPI are being extensively studied in oncologic and non-oncologic positron emission tomography/computed tomography (PET/CT) and, to a lesser extent, PET/MRI, both in Europe and Asia.

In this open-label, single-arm, single-center prospective study, the investigators will recruit 10 patients with known primary sclerosing cholangitis (PSC) who have previously undergone other modalities for the evaluation of hepatic fibrosis, such as liver biopsy and/or transient elastography (FibroScan) and/or MR liver elastography and/or US liver elastography.No healthy volunteers will be included. Patients will be referred to [68Ga]CBP8 or [18F]-FAPI-74 PET/MRI by their primary treating physicians (e.g., hepatologist). After a phone-call pre-screening, electronic medical records verification, and a screening visit, subjects will be imaged with [68Ga]CBP8 or [18F]-FAPI-74 PET/MRI. A blood draw might also be performed to measure serum biomarkers of liver fibrosis.

Transient liver elastography has a diagnostic accuracy ranging from 65% in the initial stages to 90% for severe fibrosis in the setting of PSC. There is no data regarding the use of [68Ga]CBP8 PET/MRI to diagnose or quantify fibrosis in PSC. Therefore, the investigators lack sufficient evidence to estimate power with a reasonable degree of certainty. By enrolling 10 patients for this initial pilot study in the evaluation of hepatic/biliary fibrosis with [68Ga]CBP8 PET/MRI, the investigators will be able to acquire enough data to determine the optimal sample size for a larger study. A paired McNemar's test will be used for hypothesis testing regarding differences in sensitivity, specificity, accuracy, negative predictive value, and positive predictive value between [68Ga]CBP8 PET/MRI and FibroScan. Moreover, the investigators will analyze quantitative features of PET (SUV) and obtain their correlation to the actual fibrosis as reported by the gold standard test. These will be performed using Spearman's correlation coefficient and regression analysis.

Conditions
PSC
Being tested
Radiotracer Injection, Contrast Media, Magnetic Resonance, Imaging
Keywords
PSC, [18F]-FAPI-74, [68Ga]CBP8-PET, PET/MR, Fibrosis
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotracer InjectionDrug

    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 ResonanceDrug

    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.

  • ImagingDiagnostic 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 groups in NCT06252610
Study groupRoleWhat they receive
PSCPopulation will be consecutive patients with PSC, who will be referred to us by the MGB-affiliated hepatologists.
Receives: Drug: Radiotracer Injection; Drug: Contrast Media, Magnetic Resonance; Diagnostic Test: Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: (1-2 Months)

  2. 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.

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

Secondary outcomes (2)

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

    Compare fibrosis levels as measured by [68Ga]CBP8 or [18F]FAPI-74-PET/MRI to selected fibrosis plasma biomarkers, fibroscan, and derived scores.

    Measured: 1-2 Months

  2. Correlation of PET parameters with MRI parameters

    Compare fibrosis levels with gadoxetate contrast-enhanced and other MRI parameters (e.g., MRCP)

    Measured: 1-2 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start10 Dec 2026 (estimated)
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06252610
Sponsor's protocol ID
2022P002225
Status last verified
Oct 2026
First submitted
2 Feb 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 2699167

  • 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.

    PubMed 25869391

  • 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.

    PubMed 20656832

  • 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.

    PubMed 32130494

  • Vuppalanchi R, Sanyal AJ. Myths and mysteries about staging hepatic fibrosis by fibroscan. Clin Gastroenterol Hepatol. 2015 Apr;13(4):780-2. doi: 10.1016/j.cgh.2014.10.030. Epub 2014 Nov 5. No abstract available.

    PubMed 25451885

  • Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.

    PubMed 31161770

  • 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.

    PubMed 26436860

  • 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.

    PubMed 29531862

  • Corpechot C, Gaouar F, El Naggar A, Kemgang A, Wendum D, Poupon R, Carrat F, Chazouilleres O. Baseline values and changes in liver stiffness measured by transient elastography are associated with severity of fibrosis and outcomes of patients with primary sclerosing cholangitis. Gastroenterology. 2014 Apr;146(4):970-9; quiz e15-6. doi: 10.1053/j.gastro.2013.12.030. Epub 2013 Dec 31.

    PubMed 24389304

  • Ehlken H, Wroblewski R, Corpechot C, Arrive L, Rieger T, Hartl J, Lezius S, Hubener P, Schulze K, Zenouzi R, Sebode M, Peiseler M, Denzer UW, Quaas A, Weiler-Normann C, Lohse AW, Chazouilleres O, Schramm C. Validation of Transient Elastography and Comparison with Spleen Length Measurement for Staging of Fibrosis and Clinical Prognosis in Primary Sclerosing Cholangitis. PLoS One. 2016 Oct 10;11(10):e0164224. doi: 10.1371/journal.pone.0164224. eCollection 2016.

    PubMed 27723798

  • 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.

    PubMed 30954939

  • Altmann A, Haberkorn U, Siveke J. The Latest Developments in Imaging of Fibroblast Activation Protein. J Nucl Med. 2021 Feb;62(2):160-167. doi: 10.2967/jnumed.120.244806. Epub 2020 Oct 30.

    PubMed 33127618

  • Giesel FL, Adeberg S, Syed M, Lindner T, Jimenez-Franco LD, Mavriopoulou E, Staudinger F, Tonndorf-Martini E, Regnery S, Rieken S, El Shafie R, Rohrich M, Flechsig P, Kluge A, Altmann A, Debus J, Haberkorn U, Kratochwil C. FAPI-74 PET/CT Using Either 18F-AlF or Cold-Kit 68Ga Labeling: Biodistribution, Radiation Dosimetry, and Tumor Delineation in Lung Cancer Patients. J Nucl Med. 2021 Feb;62(2):201-207. doi: 10.2967/jnumed.120.245084. Epub 2020 Jun 26.

    PubMed 32591493

  • 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.

    PubMed 23063597

Questions about this trial

What is this clinical trial studying?

An observational study of PSC, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Onofrio Catalano, MD, Ph.D (617-724-4030, ocatalano@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy in detection of fibrotic components in patients with PSC (time frame: (1-2 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06252610, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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