Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT04748094
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of Abdominal Organ Motion Using MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI Motion Management SOP', 'timeFrame': 'through study completion, approximately 6 months', 'description': 'Development and implementation of an MRI protocol suitable for organ motion characterisation for the abdomen. Determination of the benefit of motion management strategies for abdominal radiotherapy.'}], 'secondaryOutcomes': [{'measure': 'Quantification of motion', 'timeFrame': 'through study completion, approximately 6 months', 'description': 'Quantification of intra-abdominal inter and intra-fraction motion with and without abdominal compression and visually guided breath holds using MR imaging. Comparative analysis of comparable treatment plans with and without abdominal compression and visually guided breath holds on relevant treatment planning software for PBT and MRL. Development of process to evaluate patient compliance when using a commercial available abdominal compression belt and visually guided breath-hold.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to quantify abdominal motion in order to optimise MR imaging. The study will compare three-motion management strategies a) free-breathing, b) using an abdominal compression belt and c) using MRI-compatible visually guided breath-holds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients or staff at The Christie NHS Foundation Trust', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy volunteers\n\n* 18 years or older,\n* no MRI contra-indications\n* must agree to registration as a non-patient in CWP (the local electronic healthcare records system) and have their MRIs read and reviewed for incidental findings by a clinical radiologist\n\nPatient Volunteers\n\n* undergoing radiotherapy to the abdominal region at the Christie NHS Foundation Trust\n* Over 18 years of age\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* Pregnancy\n* Colostomy'}, 'identificationModule': {'nctId': 'NCT04748094', 'acronym': 'QUANTUM', 'briefTitle': 'Quantification of Abdominal Organ Motion Using MRI', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'Quantification of Abdominal Organ Motion Using Magnetic Resonance Imaging (MRI)', 'orgStudyIdInfo': {'id': 'CFTSp166'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Free-breathing versus Compression', 'description': 'This cohort of volunteers and patients will undergo imaging on the MR-Linac investigating free-breathing motion, and comparing it to motion using an abdominal compression device.', 'interventionNames': ['Device: Compression belt']}, {'label': 'Free-breathing versus Breath-holding', 'description': 'This cohort of volunteers and patients will undergo imaging on the MRSim investigating free-breathing motion and comparing it to visually-guided breath-hold motion (and reproducibility).', 'interventionNames': ['Other: Visual Guided Breath-hold']}], 'interventions': [{'name': 'Compression belt', 'type': 'DEVICE', 'description': 'The abdominal belt is fastened around the lower abdomen and inflated (like an inner tube) to apply pressure to the belly and reduce the motion associated with respiration (breathing)', 'armGroupLabels': ['Free-breathing versus Compression']}, {'name': 'Visual Guided Breath-hold', 'type': 'OTHER', 'description': 'A small tracer will be place on the lower abdomen that will feedback to a computer screen that will have graphics to show you if the participant is in breath-hold or not.', 'armGroupLabels': ['Free-breathing versus Breath-holding']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}