Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.

NCT06252493 | Recruiting FDA Drug

• 1 other identifier: 2019P001913
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In this study twenty-five (25) subjects with Crohn's disease scheduled for possible surgical intervention will be recruited for this study and a PET/MR scan using the collagen-binding radiotracer will be performed. The study aims to establish the performance figures of PET/MR using \[68Ga\]CBP8-PET for preoperative detection and differentiation of strictures with a fibrotic component in patients with Crohn's disease by using surgical and histologic findings (when available) as the standard for comparison. Furthermore, the investigators will determine the performance figures with which strictures are identified and characterized by PET/MR using \[68Ga\]CBP8-PET compared to each modality in isolation (PET alone or MR alone). Blood and tissue markers for fibrostenosis will be explored (either predictive or as biomarkers for fibrotic burden), using histologic and molecular testing by using surgical and histologic findings (when available) as the standard for comparison. Lastly the investigators want to determine the performance figures with which strictures are identified and characterized by PET/MR using \[68Ga\]CBP8-PET compared to each modality in isolation (PET alone or MR alone).

Conditions

Crohn Disease

Keywords

PET/MR; Crohn Disease; [68Ga]CBP8-PET; Enterography; Fibrosis; Inflammatory Strictures

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Fibrotic Strictures with [68Ga]CBP8-PET PET/MRE.

  The primary endpoint of the study is to evaluate the performance of PET/MRE using \[68Ga\]CBP8- PET in detecting strictures containing a fibrotic component. This performance will also be compared with that of PET alone and MR enterography alone that will be acquired during the scan as well as to the findings noted at the time of surgical intervention and/or upon histologic analysis, when possible.

  From date of PET/MRE examination to date of final Histopathology result (1-2 Months)

Secondary Outcomes (2)

• Correlation of [68Ga]CBP8-Uptake with Degree of Fibrosis.

  (1-2 Months)

• Detection Rate of Fibrotic Strictures with Multiparametric [68Ga]CBP8-PET/MRE.

  (1-2 Months)

Study Arms (1)

Crohn Disease

Patients with confirmed/suspected Crohn's disease scheduled for operative management/surgical intervention

Drug: Radiotracer Injection; Drug: Contrast Media, Magnetic Resonance; Diagnostic Test: Blood Draw; Drug: Glucagon; Diagnostic Test: Imaging; Drug: Oral contrast media application

Interventions

Radiotracer Injection DRUG

Injection of Gallium-68 labeled collagen binding probe 8 (\[68Ga\]CBP8): All subjects will undergo placement of an intravenous catheter (IV). The catheter will be flushed post-injection of \[68Ga\]CBP8 with 0.9% saline solution. The subjects will be positioned on the scanner table; support devices under the back and/or legs will be used as needed to enable the patient to comfortably maintain his/her position throughout the scan; Up to 15 mCi of \[68Ga\]CBP8 will be administered. The injected dose and the time of injection will be recorded; Post scan: The catheter will be removed. The subject will be asked to void again immediately after the scan and he/she will be counseled on the importance of continuing to drink fluids for several more hours in order to increase urine flow rate and minimize the radiation dose to the bladder wall.

Crohn Disease

Contrast Media, Magnetic Resonance DRUG

Dotarem 20ml will be injected during acquisition of contrast enhanced T1weighted fat saturated sequences, in keeping with standard of care MR enterography.

Crohn Disease

Blood Draw DIAGNOSTIC_TEST

All subjects will undergo placement of an intravenous catheter (IV). Through the same catheter, 10 mL of venous blood will be collected to evaluate blood markers for fibrostenosis.

Crohn Disease

Glucagon DRUG

Glucagon will be injected into the subject's indwelling i.v. catheter (0.3-0.5 mg) before imaging acquisition; or intramuscularly (1-2 mg) prior to imaging the abdomen and pelvis. A second administration of IV glucagon (0.3-0.5mg) may take place during image acquisition.

Crohn Disease

Imaging DIAGNOSTIC_TEST

MR and PET images of the abdomen and pelvis will be acquired using the Siemens 3 Tesla Biograph mMR scanner. Multiple anatomical and functional imaging sequences may be run to assess specific image quality measures in addition to those used for anatomical diagnosis. Among the sequences, patients will undergo a full set of standard of care MR enterography sequences to ensure they get at least same quality of study and of clinical information they would gain from a clinical study. Certain MR sequences scans may be repeated after varying a limited range of pulse sequence parameters to assess their effect on the image contrast, image artifacts and signal to noise ratio.

Crohn Disease

Oral contrast media application DRUG

Patients will be invited to drink as much as possible of an oral contrast solution consisting of a mixture of 1500-2000 ml of dilute barium or sorbitol (VoLumen or Breeza) and water. Breeza, and in the past VoLumen, is routine clinical practice at MGH. The solution comes already prepared in bottles, so there is no need to dilute or prepare. The investigators will just hand the bottle to the patient and will ask the patient to start drinking \~1 hour before the scan. By routine practice at MGH, the investigators give 3-4 bottles of Breeza, about 1500-2000ml.

Crohn Disease

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

Twenty-five (25) subjects with Crohn's disease will be recruited for this study. The subjects will be patients with confirmed/suspected Crohn's disease scheduled for operative management/surgical intervention.

You may qualify if:

• Age greater than 18 years
• Biopsy confirmed/suspected Crohn's disease
• Ability to give written informed consent

You may not qualify if:

• Electrical implants such as cardiac pacemaker or perfusion pump;
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, 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;
• eGFR of less than 30 mL/min/1.73 m2 within the past 90 days;
• Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test will be required for females of child-bearing age before the subject can participate);
• History of claustrophobia or any other condition considered likely to preclude the patient from lying comfortably in the MR/PET scanner for the duration of the exam;
• Research-related radiation exposure exceeds current Radiation Safety Committee guidelines (i.e. 50 mSv in the prior 12 months);
• BMI \> 33 (limit of the PET/MR table);
• Co-morbid conditions known to cause fibrosis that may interfere with the results of the exam (e.g., retroperitoneal fibrosis, mesenteric panniculitis, desmoid tumor etc.)
• Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);

Sponsors & Collaborators

• Takeda Development Center Americas, Inc.: collaborator
• 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

RECRUITING

Related Publications (7)

• Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med. 2009 Nov 19;361(21):2066-78. doi: 10.1056/NEJMra0804647. No abstract available.

  PMID: 19923578 BACKGROUND

• Lenze F, Wessling J, Bremer J, Ullerich H, Spieker T, Weckesser M, Gonschorrek S, Kannengiesser K, Rijcken E, Heidemann J, Luegering A, Schober O, Domschke W, Kucharzik T, Maaser C. Detection and differentiation of inflammatory versus fibromatous Crohn's disease strictures: prospective comparison of 18F-FDG-PET/CT, MR-enteroclysis, and transabdominal ultrasound versus endoscopic/histologic evaluation. Inflamm Bowel Dis. 2012 Dec;18(12):2252-60. doi: 10.1002/ibd.22930. Epub 2012 Feb 22.

  PMID: 22359277 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

• Pellino G, Nicolai E, Catalano OA, Campione S, D'Armiento FP, Salvatore M, Cuocolo A, Selvaggi F. PET/MR Versus PET/CT Imaging: Impact on the Clinical Management of Small-Bowel Crohn's Disease. J Crohns Colitis. 2016 Mar;10(3):277-85. doi: 10.1093/ecco-jcc/jjv207. Epub 2015 Nov 15.

  PMID: 26574490 BACKGROUND

• Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.

  PMID: 28381537 BACKGROUND

• Blandino AA, Caravan P, Ricciardi R, Bordeianou LG, Kunitake H, Goldstone RN, Drage MG, Zhang ML, Ananthakrishnan AN, Catalano OA. Collagen-binding probe PET/MR for distinguishing fibrotic from inflammatory strictures in Crohn's disease. Eur J Nucl Med Mol Imaging. 2026 Feb 17. doi: 10.1007/s00259-025-07741-x. Online ahead of print.

  PMID: 41699282 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples (10 ml per patient) which will be used to explore blood markers for fibrostenosis (either predictive or as biomarkers for fibrotic burden) using either serum proteomics analysis (extracellular matrix proteins using Nordic Biosciences or other proteomic platforms, e.g., Olink or similar) or serum exosome isolation for exo-miRNA profiling. * Tissue specimens obtained from intestinal (large and/or small bowel) surgical resections and/or endoscopic biopsies.

MeSH Terms

Conditions

Crohn Disease; Fibrosis

Interventions

Contrast Media; Magnetic Resonance Spectroscopy; Blood Specimen Collection; Glucagon; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; 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; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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: Associate Professor Harvard Medical School, PET/MR Translation Officer, Medical Director PET/MR at the Athinoula A. Martinos Center for Biomedical Imaging

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 9, 2024
• Study Start: December 19, 2023
• Primary Completion (Estimated): December 19, 2027
• Study Completion (Estimated): December 19, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)