Inflammatory Bowel DiseasesROOFTOPS-IBDNCT05817266
Role of FCI in the Detection of Proctosigmoiditis Caused by IBD
A study testing Field-cycling imaging (FCI) in people with Inflammatory Bowel Diseases and Proctosigmoiditis, run by NHS Grampian at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Proctosigmoiditis
- What is being tested?
- Field-cycling imaging (FCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2024to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Role of Field-Cycling Imaging in the Detection of Proctosigmoiditis Caused by Inflammatory Bowel Disease
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Proctosigmoiditis
- Being tested
- Field-cycling imaging (FCI)
- Keywords
- Field-Cycling Imaging (FCI), Proctosigmoiditis, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Proctocolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Field-cycling imaging (FCI)Device
FCI scan
| Study group | Role | What they receive |
|---|---|---|
| Proctosigmoiditis | Experimental | Participants with confirmed proctosigmoiditis will undergo one FCI scan. Receives: Device: Field-cycling imaging (FCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline
Secondary outcomes (1)
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).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completion31 Mar 2024
Why it stopped: Funding period ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Collaborators
- University of Aberdeen
- Responsible party
- Sponsor
- Investigators
- Gillian Bain, Dr, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817266
- Sponsor's protocol ID
- 1-093-22
- Acronym
- ROOFTOPS-IBD
- Status last verified
- May 2024
- First submitted
- 10 Mar 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Field-Cycling Imaging in the Detection of Proctosigmoiditis Caused by Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05817266
- Acronym / sponsor ID
- ROOFTOPS-IBD / 1-093-22
- Conditions
- Inflammatory Bowel Diseases, Proctosigmoiditis
- Keywords
- Field-Cycling Imaging (FCI), Proctosigmoiditis, Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding period ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NHS GrampianOther government
- Collaborators
- University of Aberdeen
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proctosigmoiditis | Experimental | Device: Field-cycling imaging (FCI)Participants with confirmed proctosigmoiditis will undergo one FCI scan. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Field-cycling imaging (FCI)FCI scan | Device | Proctosigmoiditis |
Primary outcome
Detection of proctosigmoiditis assessed by field-cycling imaging (FCI) scan
Time frame: At baseline
Validation of FCI T1 dispersion profiles as non-invasive technology able to detect proctosigmoiditis in participants with inflammatory bowel disease (IBD).
1 secondary outcome
Extent of proctosigmoiditis measured by field-cycling imaging (FCI) scan
Time frame: At baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gillian Bain, Dr principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Field-cycling imaging (FCI) in people with Inflammatory Bowel Diseases and Proctosigmoiditis, run by NHS Grampian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of proctosigmoiditis assessed by field-cycling imaging (FCI) scan (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.