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RECRUITING
NCT06252493

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2023-12-19

Completion Date

2029-12-19

Last Updated

2026-03-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

DRUG

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.

DIAGNOSTIC_TEST

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.

DRUG

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.

DIAGNOSTIC_TEST

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.

DRUG

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.

Locations (1)

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

Charlestown, Massachusetts, United States