Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT07302503
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study Evaluating brainQuant's Ability to Detect Alterations in White Matter in Diffusion MRI, Indicative of Post-traumatic Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070627', 'term': 'Chronic Traumatic Encephalopathy'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020208', 'term': 'Brain Injury, Chronic'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes found in MRI diffusion tensor imaging of professional football players', 'timeFrame': 'day 1 post-consultation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Traumatic Encephalopathy', 'Post-traumatic lesions', 'Neurodegenerative brain abnormalities', 'Professional soccer players'], 'conditions': ['Chronic Traumatic Encephalopathy']}, 'descriptionModule': {'briefSummary': 'Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease described in boxing, but also in contact sports such as American football.\n\nSoccer, due to repeated headers, could also be associated, albeit to a lesser degree, with the development of this type of pathology.\n\nIndeed, it has been shown that playing soccer can be accompanied by cognitive impairments, and neurodegenerative brain abnormalities have been described in neuropathology studies of former professional soccer players. Subradiological brain abnormalities have been found in multimodal MRI in various sports. Similarly, a decrease in cognitive performance has been described.\n\nThe discovery of this type of anomaly in a population of professional footballers nearing the end of their careers could lead to:\n\n* The implementation of appropriate monitoring for professional footballers through early detection of lesions via MRI and cognitive disorders\n* The implementation of preventative measures for professional footballers, but also for amateur footballers from a very young age.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '32 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male subject aged 32 to 60 years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subject\n* Aged 32 to 60 years inclusive\n* Professional footballer nearing the end of their career or recently retired, or subject who has never regularly participated in sports that expose them to head trauma (particularly rugby, basketball, handball, American football, hockey, combat sports, etc.)\n\nExclusion Criteria:\n\n\\- Subject who expressed their opposition to participating in the study'}, 'identificationModule': {'nctId': 'NCT07302503', 'acronym': 'BQ TC-foot', 'briefTitle': "Pilot Study Evaluating brainQuant's Ability to Detect Alterations in White Matter in Diffusion MRI, Indicative of Post-traumatic Lesions", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': "Pilot Study Evaluating brainQuant's Ability to Detect Alterations in White Matter in Diffusion MRI, Indicative of Post-traumatic Lesions", 'orgStudyIdInfo': {'id': '9451'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane KREMER, Stéphane KREMERMD, PhD', 'role': 'CONTACT', 'email': 'stephane.kremer@chru-strasbourg.fr', 'phone': '33 3 88 12 78 48'}, {'name': 'Stéphane KREMER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service d'Imagerie 2 - Réanimation - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Stéphane KREMER, MD, PhD', 'role': 'CONTACT', 'email': 'stephane.kremer@chru-strasbourg.fr', 'phone': '33 3 88 12 78 48'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}