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

N

NHS Grampian

Status

Withdrawn

Conditions

Inflammatory Bowel Diseases
Proctosigmoiditis

Treatments

Device: Field-cycling imaging (FCI)

Study type

Interventional

Funder types

Other

Identifiers

NCT05817266
1-093-22

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

16 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Proctosigmoiditis
Experimental group
Description:
Participants with confirmed proctosigmoiditis will undergo one FCI scan.
Treatment:
Device: Field-cycling imaging (FCI)

Trial contacts and locations

1

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Central trial contact

Celia G Alvarez Campano, Dr

Data sourced from clinicaltrials.gov

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