Clinical trial NCT05817266: Role of FCI in the Detection of Proctosigmoiditis Caused by IBD
Official title: Role of Field-Cycling Imaging in the Detection of Proctosigmoiditis Caused by Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Proctosigmoiditis
Keywords: Field-Cycling Imaging (FCI)
Proctosigmoiditis
Inflammatory Bowel Disease
Lead sponsor: NHS Grampian
Sponsor class: OTHER_GOV
Collaborators: name: University of Aberdeen
First posted: 2023-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of proctosigmoiditis assessed by field-cycling imaging (FCI) scan
timeFrame: At baseline
Secondary outcomes:
measure: Extent of proctosigmoiditis measured by field-cycling imaging (FCI) scan
timeFrame: At baseline
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
Study officials:
affiliation: NHS Grampian
name: Gillian Bain, Dr
role: PRINCIPAL_INVESTIGATOR
References: