RECRUITING

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

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Conditions

Crohn DiseasePET/MR[68Ga]CBP8-PETEnterographyFibrosisInflammatory Strictures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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.

Quick Facts

Study Start:2023-12-19
Study Completion:2025-12-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06252493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than 18 years
  2. * Biopsy confirmed/suspected Crohn's disease
  3. * Ability to give written informed consent
  1. * Electrical implants such as cardiac pacemaker or perfusion pump;
  2. * 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;
  3. * eGFR of less than 30 mL/min/1.73 m2 within the past 90 days;
  4. * Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test will be required for females of child-bearing age before the subject can participate);
  5. * 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;
  6. * Research-related radiation exposure exceeds current Radiation Safety Committee guidelines (i.e. 50 mSv in the prior 12 months);
  7. * BMI \> 33 (limit of the PET/MR table);
  8. * 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.)
  9. * Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);

Contacts and Locations

Study Contact

Onofrio Catalano, MD, Ph.D
CONTACT
617-724-4030
ocatalano@mgh.harvard.edu
Diandrea Galloway
CONTACT
617-643-1407
dgalloway@mgh.harvard.edu

Principal Investigator

Onofrio Catalano, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

Study Locations (Sites)

Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Charlestown, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Onofrio Catalano, MD, Ph.D, PRINCIPAL_INVESTIGATOR, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-19
Study Completion Date2025-12-19

Study Record Updates

Study Start Date2023-12-19
Study Completion Date2025-12-19

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Crohn Disease