Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-09 @ 4:22 PM
Study NCT ID:
NCT05817266
Status:
WITHDRAWN
Last Update Posted:
2024-05-14
First Post:
2023-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of FCI in the Detection of Proctosigmoiditis Caused by IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D011350', 'term': 'Proctocolitis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D011349', 'term': 'Proctitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012810', 'term': 'Sigmoid Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding period ended', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of proctosigmoiditis assessed by field-cycling imaging (FCI) scan', 'timeFrame': 'At baseline', 'description': 'Validation of FCI T1 dispersion profiles as non-invasive technology able to detect proctosigmoiditis in participants with inflammatory bowel disease (IBD).'}], 'secondaryOutcomes': [{'measure': 'Extent of proctosigmoiditis measured by field-cycling imaging (FCI) scan', 'timeFrame': 'At baseline', 'description': 'Validation of FCI T1 dispersion profiles as a clinical tool for defining the extent of proctosigmoiditis in participants with inflammatory bowel disease (IBD).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Field-Cycling Imaging (FCI)', 'Proctosigmoiditis', 'Inflammatory Bowel Disease'], 'conditions': ['Inflammatory Bowel Diseases', 'Proctosigmoiditis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nFCI 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.\n\nIn this proof-of-concept study, the investigators will explore the ability of FCI to detect active disease in patients with PS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with a diagnosis of proctosigmoiditis, on the basis of a compatible history and previous flexible sigmoidoscopy\n* Participants who are already under follow up in the NHS Grampian IBD clinic\n* Participants must be between 16 and 80 years old\n* Participants who meet the safety criteria for undergoing an MRI scan\n* Participants who are able to fit inside the scanner\n* Participants must be able to give fully informed consent\n* Participants must be mobile enough to be positioned onto the FCI scanner couch\n\nExclusion Criteria:\n\n* MRI-incompatible conditions, as detected in the MRI safety screening sheet\n* Participants under 16 years old\n* Participants who are unable to communicate in English\n* Participants who are unable to give fully informed consent\n* Women who are pregnant\n* Restrictions to mobility that would prevent the correct positioning in the scanner\n* Previous major abdominal surgery\n* Any known significant comorbid disease that might interfere with treatment\n* Malignancy or other conditions that would significantly reduce life expectancy\n* Participants who suffer from claustrophobia'}, 'identificationModule': {'nctId': 'NCT05817266', 'acronym': 'ROOFTOPS-IBD', 'briefTitle': 'Role of FCI in the Detection of Proctosigmoiditis Caused by IBD', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Grampian'}, 'officialTitle': 'Role of Field-Cycling Imaging in the Detection of Proctosigmoiditis Caused by Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '1-093-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proctosigmoiditis', 'description': 'Participants with confirmed proctosigmoiditis will undergo one FCI scan.', 'interventionNames': ['Device: Field-cycling imaging (FCI)']}], 'interventions': [{'name': 'Field-cycling imaging (FCI)', 'type': 'DEVICE', 'description': 'FCI scan', 'armGroupLabels': ['Proctosigmoiditis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZD', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Gillian Bain, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Grampian'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Grampian', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Aberdeen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}