Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-28 @ 2:30 PM
Study NCT ID:
NCT04833335
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASL in Brain Metastasis MRI Following Gamma Knife Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-04-02', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence', 'timeFrame': 'Evolution between Baseline MRI, 1 and 6 month follow up MRI', 'description': 'Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after.'}], 'secondaryOutcomes': [{'measure': 'ASL Perfusion: Cerebral blood flow measurements', 'timeFrame': 'Baseline MRI, 1 and 6 month follow up MRI'}, {'measure': 'Interreader correlation', 'timeFrame': 'Baseline MRI, 1 and 6 month follow-up MRI', 'description': 'Two neuroradiologists'}, {'measure': 'Morphological analysis of the lesions', 'timeFrame': 'Baseline MRI, 1 and 6 month follow-up MRI', 'description': 'Lesion size, oedema'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASL', 'MRI', 'Metastasis', 'Gamma knife', 'Radionecrosis'], 'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment.\n\nThe primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment', 'detailedDescription': 'The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brain metastasis from histologically proven tumor\n* GK treatment within 4 month prior to the inclusion\n* Lesions suspected of progression/ radionecrosis :\n\n i.e.≥ 25% of the size progression\n* Lesion size: gadolinium enhanced part of the tumour ≥1 cm\n\nExclusion Criteria:\n\n* Pregnancy\n* Medical history of primitive brain tumour\n* MRI incompatibility/ medical history of contrast agent allergy\n* Claustrophobia\n* Patient unable to consent\n* Epilepsia/recent stroke\n* Patients participating in other studies\n* Patients without health care insurance'}, 'identificationModule': {'nctId': 'NCT04833335', 'acronym': 'GK-ASL', 'briefTitle': 'ASL in Brain Metastasis MRI Following Gamma Knife Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.', 'orgStudyIdInfo': {'id': 'APHP190736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus', 'description': 'Inclusion visit, 1 month later, 6 month later', 'interventionNames': ['Other: MRI perfusion sequence']}], 'interventions': [{'name': 'MRI perfusion sequence', 'type': 'OTHER', 'otherNames': ['Arterial Spin Labeling (ASL)'], 'description': 'Quantitative analysis', 'armGroupLabels': ['Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Natalia SHOR, MD', 'role': 'CONTACT', 'email': 'natalia.shor@aphp.fr'}, {'name': 'Nadya pyatigorskaya, MD', 'role': 'CONTACT', 'email': 'nadya.pyatigorskaya@aphp.fr'}], 'facility': 'Service de neuroradiologie, hôpital Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Natalia SHOR, MD', 'role': 'CONTACT', 'email': 'shor.natalia@icloud.com', 'phone': '+330661884335'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}