Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT06994702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate quality of a synthetic scanner generated from an MRI performed in the position of cerebral radiotherapy treatment with 2 thermoformed masks', 'timeFrame': '1 day', 'description': 'The quality is measured in Hounsfield Units (HU) on each of the structures outlined on the MRI scans and reproduced on the sCT scans.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the quality of MRI images with and without restraint', 'timeFrame': '1 day', 'description': 'Mesure of signal-to-noise ratio (SNR)'}, {'measure': 'Comparison of the quality of MRI images with and without restraint', 'timeFrame': '1 day', 'description': 'Mesure of contrast-to-noise ratio (CNR)'}, {'measure': 'Studying the integration of a field map into routine clinical practice', 'timeFrame': '1 day', 'description': 'Measurement of acquisition'}, {'measure': 'Studying the integration of a field map into routine clinical practice', 'timeFrame': '1 day', 'description': 'Measurement of analysis time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Synthetic CT', 'MRI'], 'conditions': ['Device Ineffective']}, 'descriptionModule': {'briefSummary': "In radiotherapy, CT scans are the reference imaging tool for treatment planning, as they provide the electron density of the tissues required to calculate the dose. Magnetic Resonance Imaging (MRI) is used as a complement to CT to contour target volumes and organs at risk. While the properties of CT allow us to determine the electron density of tissues, the properties of MRI allow us to determine the proton density of tissues. MRI therefore provides better tissue contrast, but cannot be used directly to calculate the dose. In recent years, MRI-only protocols have been introduced to remove the need for a CT examination and avoid possible MRI-CT registration errors. Dose calculations are then performed on MRI images converted into synthetic CT images (sCT) using software based on artificial intelligence (for the most recent). Various commercial solutions are available for generating these sCTs, and the ICO already has experience of evaluating them.\n\nWhile MRI scans for diagnostic purposes are performed in the free position, the generation of an sCT for treatment preparation requires the MRI scan to be performed in the radiotherapy position. For cranial lesions, a thermoformed mask fixed to the table is made for each patient. Depending on the type of treatment and its associated degree of precision, different types of mask exist at the ICO: '3-point' for normo-fractionated treatments and 'stereo' for treatments of 1 to 3 fractions. The use of these masks during the MRI examination can interfere with the correct positioning of the antennae and thus lead to a deterioration in the quality of the images obtained (MRI and, by repercussion, sCT).\n\nThe aim of this study was to evaluate the impact of the 2 thermoformed masks used at the ICO on the quality of a synthetic scan for 3 healthy volunteers."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male \\> 18 years\n2. Health professional practising at the ICO\n3. Volunteer who has signed the consent form\n4. Volunteer available to carry out the 3 MRI scans\n\nExclusion Criteria:\n\n1. Claustrophobia\n2. Foreign metal objects (metal splinters, filings, shotgun pellets, etc.)\n3. Woman'}, 'identificationModule': {'nctId': 'NCT06994702', 'acronym': 'ISTRI', 'briefTitle': 'Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Evaluation of the Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment: Feasibility Study', 'orgStudyIdInfo': {'id': 'ICO-2024-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI with thermoformed masks', 'description': 'MRI performed in the position of cerebral radiotherapy treatment', 'interventionNames': ['Device: MRI without mask', 'Device: MRI with mask 1', 'Device: MRI with mask 2']}], 'interventions': [{'name': 'MRI without mask', 'type': 'DEVICE', 'description': 'MRI in position of cerebral radiotherapy treatment without mask', 'armGroupLabels': ['MRI with thermoformed masks']}, {'name': 'MRI with mask 1', 'type': 'DEVICE', 'description': 'MRI in position of cerebral radiotherapy treatment with mask 1', 'armGroupLabels': ['MRI with thermoformed masks']}, {'name': 'MRI with mask 2', 'type': 'DEVICE', 'description': 'MRI in position of cerebral radiotherapy treatment with mask 2', 'armGroupLabels': ['MRI with thermoformed masks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49055', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Stéphane DUFRENAIX', 'role': 'CONTACT', 'email': 'stephane.dufreneix@ico.unicancer.fr', 'phone': '02 41 35 28 83'}], 'facility': "Institut de Cancerologie de L'Ouest", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Laëtitia HIMPE', 'role': 'CONTACT', 'email': 'promotionrc@ico.unicancer.fr', 'phone': '0240679747', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Stéphane DUFRENAIX', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}