Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT04749134
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Developed and optimised of MRI scanning sequences for use in clinical radiotherapy practice in MR guided radiotherapy', 'timeFrame': 'Through study completion - up to 5 years', 'description': 'on-going development of MRI protocols to be released for clinical use'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Focus of the Study is MRI Sequence Development']}, 'descriptionModule': {'briefSummary': 'Non-patient volunteers will be scanned on the MR-Linac and MRSIM to facilitate the development, optimisation and validation of MRI protocols at The Christie NHS Foundation Trust.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Personnel at The Christie NHS Foundation Trust', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to provide written consent\n* Volunteers must undergo and satisfy MRI safety screening\n* Volunteers must be ≥ 16 years of age\n* Participants must agree to registration as a non-patient in CWP (the Trust's Electronic Health Record - EHR- system) and have their MRIs read and reported for incidental findings by a clinical radiologist\n\nExclusion Criteria:\n\n* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form\n* Unable to tolerate MRI scan\n* Known Pregnancy\n* Known or suspected pathology in body region to be scanned\n* Member of study team"}, 'identificationModule': {'nctId': 'NCT04749134', 'acronym': 'MINION', 'briefTitle': 'MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers', 'orgStudyIdInfo': {'id': 'CFTSp170'}}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Cynthia Eccles, DPhil', 'role': 'CONTACT', 'email': 'cynhia.eccles1@nhs.net', 'phone': '16187999'}], 'facility': 'The Christie NHS FT', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Radiotherapy Research and Development', 'investigatorFullName': 'Cynthia Eccles', 'investigatorAffiliation': 'The Christie NHS Foundation Trust'}}}}