Using advanced imaging to assess Crohn's disease

Evaluation of PET/MR Enterography for Differentiation of Fibrotic and Inflammatory Strictures in Patients With Crohn's Disease Using a Collagen-binding Radiotracer.

This study is testing a new type of imaging to see if it can better identify certain problems in the intestines of people with Crohn's disease who might need surgery.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Charlestown, Massachusetts)
• Trial ID: NCT06252493 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with biopsy-confirmed or suspected Crohn's disease.

Not a fit: Patients with electrical or ferromagnetic implants, severe renal impairment, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve preoperative assessment and treatment planning for patients with Crohn's disease by providing more accurate imaging of strictures.

How similar studies have performed: While PET/MR imaging is a relatively novel approach, previous studies have shown promise in using similar imaging techniques for other conditions, suggesting potential for success in this context.

Eligibility criteria

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 this trial is running

Charlestown, Massachusetts

• 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

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