Role of FCI in the Detection of Proctosigmoiditis Caused... | NCT05817266

Studies
Role of FCI in the Detection of Proctosigmoiditis Caused by IBD

NCT05817266

Sponsor

NHS Grampian

Status

Withdrawn

Last Update Posted

May 14, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Inflammatory Bowel Diseases
Proctosigmoiditis

Interventions

Field-cycling imaging (FCI)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding period ended

Expanded Access Info

Start Date

Mar 2024Estimated

Primary Completion Date

Mar 2024Estimated

Completion Date

Mar 31, 2024Actual

First Submitted Date

Mar 10, 2023

First Submission Date that Met QC Criteria

Apr 4, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2024

Last Update Posted Date

May 14, 2024Actual

Name	Class
University of Aberdeen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proctosigmoiditis	Experimental	Participants with confirmed proctosigmoiditis will undergo one FCI scan.	Device: Field-cycling imaging (FCI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Field-cycling imaging (FCI)	Device	FCI scan	Proctosigmoiditis

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gillian Bain, Dr	NHS Grampian	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Aberdeen Royal Infirmary		Aberdeen		AB25 2ZD	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D011350	Proctocolitis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided