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

Questions to ask your doctor and the trial team

• Am I likely to qualify, given my health history?
• What would I have to do, and how often would I need to visit?
• Could I get a placebo? What happens to my current treatment?
• What are the possible risks and benefits?
• Are travel or other costs covered?
• What happens after the trial ends?

Official details

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…
• 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.
• 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.
• 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.
• 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 …
• 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 patien…

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);

Locations (1)

For contacts at each site, use the official record.