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Role of FCI in the Detection of Proctosigmoiditis Caused by IBD (ROOFTOPS-IBD)

Primary Purpose

Inflammatory Bowel Diseases, Proctosigmoiditis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Field-cycling imaging (FCI)
Sponsored by
NHS Grampian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammatory Bowel Diseases focused on measuring Field-Cycling Imaging (FCI), Proctosigmoiditis, Inflammatory Bowel Disease

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants with a diagnosis of proctosigmoiditis, on the basis of a compatible history and flexible sigmoidoscopy Participants who are already under follow up in the NHS Grampian IBD clinic Participants must be between 16 and 80 years old Participants who meet the safety criteria for undergoing an MRI scan Participants who are able to fit inside the scanner Participants must be able to give fully informed consent Participants must be mobile enough to be positioned onto the FCI scanner couch Exclusion Criteria: MRI-incompatible conditions, as detected in the MRI safety screening sheet Participants under 16 years old Participants who are unable to communicate in English Participants who are unable to give fully informed consent Women who are pregnant Restrictions to mobility that would prevent the correct positioning in the scanner Previous major abdominal surgery Any known significant comorbid disease that might interfere with treatment Malignancy or other conditions that would significantly reduce life expectancy Participants who suffer from claustrophobia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Proctosigmoiditis

    Arm Description

    Participants with confirmed proctosigmoiditis will undergo one FCI scan.

    Outcomes

    Primary Outcome Measures

    Detection of proctosigmoiditis assessed by field-cycling imaging (FCI) scan
    Validation of FCI T1 dispersion profiles as non-invasive technology able to detect proctosigmoiditis in participants with inflammatory bowel disease (IBD).

    Secondary Outcome Measures

    Extent of proctosigmoiditis measured by field-cycling imaging (FCI) scan
    Validation of FCI T1 dispersion profiles as a clinical tool for defining the extent of proctosigmoiditis in participants with inflammatory bowel disease (IBD).

    Full Information

    First Posted
    March 10, 2023
    Last Updated
    April 4, 2023
    Sponsor
    NHS Grampian
    Collaborators
    University of Aberdeen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05817266
    Brief Title
    Role of FCI in the Detection of Proctosigmoiditis Caused by IBD
    Acronym
    ROOFTOPS-IBD
    Official Title
    Role of Field-Cycling Imaging in the Detection of Proctosigmoiditis Caused by Inflammatory Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NHS Grampian
    Collaborators
    University of Aberdeen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this pilot study is to explore the ability of field-cycling imaging, a new scanning technology being developed at the University of Aberdeen, to detect active disease in patients with proctosigmoiditis caused by inflammatory bowel disease.
    Detailed Description
    Field-cycling imaging (FCI) is an emerging technology that is being developed at the University of Aberdeen. It combines the use of a moderately high magnetic field (200mT) with the ability to probe low magnetic fields (0.2mT) so that image resolution can be preserved while also exploiting the high contrast present at low magnetic fields. This non-invasively provides quantitative data on the molecular dynamics in the tissues. FCI represents a potentially new, non-invasive, way of assessing the extent and activity of inflammatory bowel disease (IBD). IBD can affect the rectum and distal sigmoid colon, this condition is called Proctosigmoiditis (PS). Currently, diagnosis of IBD depends on endoscopy for direct visualisation of the upper and lower gut, using CT scanning, with its attendant use of ionising radiation, and conventional MRI, particularly for the small bowel. Determining the activity of IBD remains a continuing challenge. In this proof-of-concept study, the investigators will explore the ability of FCI to detect active disease in patients with PS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases, Proctosigmoiditis
    Keywords
    Field-Cycling Imaging (FCI), Proctosigmoiditis, Inflammatory Bowel Disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Proctosigmoiditis
    Arm Type
    Experimental
    Arm Description
    Participants with confirmed proctosigmoiditis will undergo one FCI scan.
    Intervention Type
    Device
    Intervention Name(s)
    Field-cycling imaging (FCI)
    Intervention Description
    FCI scan
    Primary Outcome Measure Information:
    Title
    Detection of proctosigmoiditis assessed by field-cycling imaging (FCI) scan
    Description
    Validation of FCI T1 dispersion profiles as non-invasive technology able to detect proctosigmoiditis in participants with inflammatory bowel disease (IBD).
    Time Frame
    At baseline
    Secondary Outcome Measure Information:
    Title
    Extent of proctosigmoiditis measured by field-cycling imaging (FCI) scan
    Description
    Validation of FCI T1 dispersion profiles as a clinical tool for defining the extent of proctosigmoiditis in participants with inflammatory bowel disease (IBD).
    Time Frame
    At baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants with a diagnosis of proctosigmoiditis, on the basis of a compatible history and flexible sigmoidoscopy Participants who are already under follow up in the NHS Grampian IBD clinic Participants must be between 16 and 80 years old Participants who meet the safety criteria for undergoing an MRI scan Participants who are able to fit inside the scanner Participants must be able to give fully informed consent Participants must be mobile enough to be positioned onto the FCI scanner couch Exclusion Criteria: MRI-incompatible conditions, as detected in the MRI safety screening sheet Participants under 16 years old Participants who are unable to communicate in English Participants who are unable to give fully informed consent Women who are pregnant Restrictions to mobility that would prevent the correct positioning in the scanner Previous major abdominal surgery Any known significant comorbid disease that might interfere with treatment Malignancy or other conditions that would significantly reduce life expectancy Participants who suffer from claustrophobia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Celia G Alvarez Campano, Dr
    Phone
    +44 1224 437828
    Email
    celia.alvarezcampano@abdn.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gillian Bain, Dr
    Organizational Affiliation
    NHS Grampian
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Role of FCI in the Detection of Proctosigmoiditis Caused by IBD

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