Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-31 @ 8:20 PM
Study NCT ID:
NCT05041569
Status:
UNKNOWN
Last Update Posted:
2023-07-25
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Using a new MRI sequence for the detection of lymph nods', 'timeFrame': '1 DAY', 'description': 'Inversion recovery pulse sequences in MRI will be used to detect lymph nods.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Description of Local Modifications of Lymph Nodes or Bundles With the FABIR Sequence in MRI']}, 'descriptionModule': {'briefSummary': "Inclusion (J0):\n\n* Information\n* Verification of inclusion and non-inclusion criteria\n* Collection of consent\n* MRI examination with injection of contrast product as part of the treatment comprising the sequences:\n\nT1 TFE 1.0 iso 3D FLAIR injected Injected elliptical venous angiography 0.4mm iso or less 3D SWIp multiecho 3D T1 injected FABIR iso without injection (added as part of care in case of suspected ASH or meningitis) FLAIR 1.0 without injection (added as part of care for suspected ASH or meningitis) T2 BFFE XD (added by search) FABIR iso injected (added by research) 3D PD T1 0.55 MSDE iso injected (added by research)\n\nClinical information (SRM on inclusion, on discharge and at 3 months and recurrence within the year) will be collected from the patient's medical file"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient presenting for imaging as part of their treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Performing an MRI injected as part of care for one of the following reasons:\n* suspicion of pathology likely to be associated with narrowing or obstruction of one or more venous sinuses (cerebral thrombophlebitis, tissue damage with venous extension, idiopathic HIC\n* venous narrowing or obstruction proven by one of the above pathologies, requiring as part of routine care an injected MRI (search for impact, monitoring, pre-therapeutic assessment or prognosis)\n* Express consent to participate in the study\n* Affiliate or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Absolute contraindication to MRI\n* Patient benefiting from a legal protection measure\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT05041569', 'acronym': 'ALTREVE', 'briefTitle': 'Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study', 'orgStudyIdInfo': {'id': 'JSY_2021_12'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI sequences', 'type': 'OTHER', 'description': 'perform additional sequences added by research'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amelie ya', 'role': 'CONTACT', 'email': 'ayavchitz@for.paris', 'phone': '0148036454'}, {'name': 'julien savatovsky', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hhopital fondation adolphe de rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'amélie YAVCHITZ', 'role': 'CONTACT', 'email': 'ayavchitz@for.paris', 'phone': '0148036454'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}