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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Injections, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "PET/MR imaging is a relatively novel imaging technique which has distinct potential advantages over conventional cross-sectional imaging (CT/MRI alone) and PET/CT imaging.The full potential of PET/MRI as an imaging modality remains largely untapped, in part due to limitation imposed by cost and time constraints of the exam."
  • "Study subjects will receive an injection of \[68Ga\]CBP8 followed by whole body MR-PET imaging acquired at 1 hour."
  • "If, as part of their routine medical care as directed by their treating physician, subjects undergo endoscopic biopsies or surgery that result in pathology samples, leftover tissue, if any, will be sent to the study Sponsor, Takeda."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a combined PET/MR scan can find narrowed areas of the bowel caused by scar tissue in people with Crohn's disease. The scan uses a radioactive tracer that attaches to collagen, a protein in scar tissue. The study will enroll 25 people who may have surgery and compare the combined scan with PET or MR scans alone.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You have suspected Crohn's disease or Crohn's disease confirmed by a biopsy (a tissue sample test).
  • You can give written consent to join.

Who can't join

  • You have electrical implants, such as a pacemaker or pump; metal implants or objects attracted to magnets; metallic tattoos; or tattoos near your eyes.
  • Your kidney filtering test (eGFR) was below 30 mL/min/1.73 m² within the past 90 days.
  • You are pregnant or breastfeeding. Women who can become pregnant must have a negative blood pregnancy test before joining.
  • You fear enclosed spaces or have another condition that keeps you from lying comfortably in the scanner for the full exam.
  • Your radiation exposure from research exceeds safety limits: 50 mSv in the past 12 months.
  • Your body mass index (BMI), a measure based on height and weight, is above 33 because of the scan table's limit.
  • You have another condition that causes scar tissue and could affect the scan results.
  • The study team decides that you are not medically suited for the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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);

Study sites (1)

MA