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

Role of Field-Cycling Imaging in the Detection of Proctosigmoiditis Caused by Inflammatory Bowel Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Inflammatory Bowel Diseases; Proctosigmoiditis
• Intervention / Treatment: Device: Field-cycling imaging (FCI)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
    • Aberdeen Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with a diagnosis of proctosigmoiditis, on the basis of a compatible history and previous 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proctosigmoiditis; Participants with confirmed proctosigmoiditis will undergo one FCI scan.	Device: Field-cycling imaging (FCI); FCI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At baseline

Collaborators and Investigators

• Sponsor: NHS Grampian
• Collaborators: University of Aberdeen
• Investigators: Principal Investigator: Gillian Bain, Dr, NHS Grampian

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Proctosigmoiditis; Field-Cycling Imaging (FCI)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Rectal Diseases; Colitis; Sigmoid Diseases; Proctitis; Inflammatory Bowel Diseases; Intestinal Diseases; Proctocolitis
• Other Study ID Numbers: 1-093-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No