NCT06252493 · Massachusetts General Hospital
Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.
What this study is about
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.
View original scientific description
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).
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.
Primary outcome measures
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)
The primary endpoint of the study is to evaluate the performance of PET/MRE using \[68Ga\]CBP8- PET in detecting strictures containing a fibrotic component. This performance will also be compared with that of PET alone and MR enterography alone that will be acquired during the scan as well as to the findings noted at the time of surgical intervention and/or upon histologic analysis, when possible.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Charlestown, Massachusetts
Collaborators
Takeda Development Center Americas, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations