Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-02 @ 5:05 AM
Study NCT ID:
NCT04704804
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2021-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'describe the differences in volumetric and dosimetric accuracy between potential planning from MRI alone by CT-synthetics generation and standard planning from CT', 'timeFrame': '3 month', 'description': 'Comparison of the contours of target volumes and organs at risk and comparison of dose distributions (dosimetries)'}], 'secondaryOutcomes': [{'measure': 'Measurement of the quality of images generated from MRI for dose calculation and images for verification of per-treatment positioning relative to the reference CT in an MRI-only workflow objective.', 'timeFrame': '3 month', 'description': 'Comparison of CT-synthetic CT images generated from MRI to the reference CT and Comparison of shifts performed during patient repositioning'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Brain Cancer']}, 'descriptionModule': {'briefSummary': 'In radiotherapy, Magnetic Resonance Imaging (MRI) is used as a complement to the CT scanner because it provides better tissue contrast and therefore more precise delineations without the need for additional irradiation. However, MRI does not allow the definition of the electronic densities of the tissues necessary for dose calculation.\n\nIn this work, we sought to measure the feasibility of a method for generating CT-synthetic images from MRI in terms of dosimetric and geometrical precision for the purpose of MRI workflow alone (see diagram). The cerebral sphere and the prostate are the two tumor locations considered. All patients will have a planning CT (reference) and an MRI in the treatment position. The contours of the structures will be contoured by a radiotherapist on both the MRI and the reference CT. Synthetic CTs will be generated from the MRI with the method of automatic assignment of densities in five classes. The volumes bypassed and the dosimetries performed will be compared. A study of the quality of the images generated from MRI for dose calculation and images for the verification of per-treatment positioning will be performed.', 'detailedDescription': "This is a prospective single-center dosimetry study that exhaustively included brain tumor and prostate cancer patients treated at the ICO Site d'Angers by external radiotherapy and prior to which they were given an MRI and a simulation CT in treatment position over a 12-month period.\n\nFor patients who agree to participate in the study, CT-synthetic images will be generated from the MRI images by automatic assignment of densities (5 classes).\n\nReference CT images from CT and synthetic CT images from MRI will be available for comparison for all eligible patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with prostate or brain cancer receiving an MRI in addition to the simulated CT scan prior to the start of their external radiotherapy treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Male or Female with a (primary) brain tumour or Male with cancer and localized (non-metastatic) prostate cancer\n3. Patient having benefited from a planning MRI scan in treatment position performed according to the new acquisition modalities (allowing the generation of CT-synthetics by automatic assignment of densities) performed since January 2020 and a planning scanner in treatment position prior to external radiotherapy.\n4. Good general condition (SP \\< 3)\n\nExclusion Criteria:\n\n1. Excluded forms of the disease,\n2. MRI-specific contraindications (claustrophobia, foreign bodies)\n3. Obesity preventing the placement of equipment (contention/antennae)\n4. Poor general condition (SP \\> or = 2) preventing the patient from standing on the table -'}, 'identificationModule': {'nctId': 'NCT04704804', 'acronym': 'PRIS', 'briefTitle': 'Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors', 'orgStudyIdInfo': {'id': 'ICO-2020-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prostate cancer', 'description': 'Man with cancer and localized (non-metastatic) prostate cancer', 'interventionNames': ['Diagnostic Test: Synthetic CT Scan']}, {'label': 'Brain cancer', 'description': 'Male or Female with a brain tumor (primitive)', 'interventionNames': ['Diagnostic Test: Synthetic CT Scan']}], 'interventions': [{'name': 'Synthetic CT Scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'method of generating CT-synthetic image from MRI', 'armGroupLabels': ['Brain cancer', 'Prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': "Institut de Cancerologie de L'Ouest", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Damien AUTRET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "INSTITUT DE CANCEROLOGIE DE L'OUEST"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}