Role of FCI in the Detection of Proctosigmoiditis Caused by IBD

Not Applicable

Withdrawn

• Conditions: Inflammatory Bowel Diseases; Proctosigmoiditis
• Interventions: Device: Field-cycling imaging (FCI)

• Registration Number: NCT05817266
• Lead Sponsor: NHS Grampian

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.

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Study Start: 2024-03
• Primary Completion: 2024-03
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proctosigmoiditis	Field-cycling imaging (FCI)	Participants with confirmed proctosigmoiditis will undergo one FCI scan.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom