Role of FCI in the Detection of Proctosigmoiditis Caused by IBD

NCT05817266 | Withdrawn

• 1 other identifier: 1-093-22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Proctosigmoiditis

Keywords

Field-Cycling Imaging (FCI); Proctosigmoiditis; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Extent of proctosigmoiditis measured by field-cycling imaging (FCI) scan

  At baseline

Study Arms (1)

Proctosigmoiditis

EXPERIMENTAL

Participants with confirmed proctosigmoiditis will undergo one FCI scan.

Device: Field-cycling imaging (FCI)

Interventions

Field-cycling imaging (FCI) DEVICE

FCI scan

Proctosigmoiditis

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Grampian: lead
• University of Aberdeen: collaborator

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Proctocolitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Proctitis; Colonic Diseases; Sigmoid Diseases; Rectal Diseases

Study Officials

• Gillian Bain, Dr

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 18, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)