Recruiting

PET/MR Enterography

Sponsor:

Massachusetts General Hospital

Code:

NCT06252493

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiotracer Injection

Contrast Media, Magnetic Resonance

Blood Draw

Glucagon

Imaging

Study Details

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

Study ID

NCT06252493

Start date

Dec 19, 2023

Status verified date

Mar, 2026

Completion date

Dec 19, 2029

Anticipated

Primary completion date

Dec 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Crohn Disease

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

Interventions

Radiotracer Injection

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.

Contrast Media, Magnetic Resonance

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

Blood Draw

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

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

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.

Oral contrast media application

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.

Primary outcome measure

  • Detection Rate of Fibrotic Strictures with [68Ga]CBP8-PET PET/MRE. [ Time Frame: From date of PET/MRE examination to date of final Histopathology result (1-2 Months) ]

Central Contacts and Locations

Central contacts

Onofrio Catalano, MD, Ph.D

617-724-4030ocatalano@mgh.harvard.edu

Diandrea Galloway

617-643-1407dgalloway@mgh.harvard.edu

Locations

Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Onforio Catalano, MD, Ph.D

617-724-4030ocatalano@mgh.harvard.edu

Diandrea Galloway

617-643-1407dgalloway@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-12.