Using advanced imaging to assess Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves 25 patients with Crohn's disease who are scheduled for possible surgery. Participants will undergo a PET/MR scan using a collagen-binding radiotracer to evaluate its effectiveness in detecting and differentiating strictures with fibrotic components. The study aims to compare the performance of PET/MR imaging against PET and MR imaging alone, using surgical and histologic findings as benchmarks. Additionally, blood and tissue markers for fibrotic burden will be explored to enhance understanding of the disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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);

Where it's running

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

Study contacts

• Principal investigator: Onofrio Catalano, MD, Ph.D — Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
• Study coordinator: Onofrio Catalano, MD, Ph.D
• Email: ocatalano@mgh.harvard.edu
• Phone: 617-724-4030

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.